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Medical glove
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Medical gloves are disposable gloves used during medical examinations and procedures to help prevent cross-contamination between caregivers and patients.[1] Medical gloves are made of different polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they come unpowdered, or powdered with corn starch to lubricate the gloves, making them easier to put on the hands.[2]
Corn starch replaced tissue-irritating lycopodium powder and talc, but even corn starch can impede healing if it gets into tissues (as during surgery). As such, unpowdered gloves are used more often during surgery and other sensitive procedures. Special manufacturing processes are used to compensate for the lack of powder.
There are two main types of medical gloves: examination and surgical. Surgical gloves have more precise sizing with a better precision and sensitivity and are made to a higher standard. Examination gloves are available either sterile or non-sterile, while surgical gloves are generally sterile.[3]
Besides medicine, medical gloves are widely used in chemical and biochemical laboratories. Medical gloves offer some basic protection against corrosives and surface contamination. However, they are easily penetrated by solvents and various hazardous chemicals, and should not be used for dishwashing or otherwise when the task involves immersion of the gloved hand in the solvent.[citation needed] Medical gloves are recommended to be worn for two main reasons:[4]
- To reduce the risk of contamination of health-care workers hands with blood and other body fluids.
- To reduce the risk of germ dissemination to the environment and of transmission from the health-care worker to the patient and vice versa, as well as from one patient to another.
History
[edit]Caroline Hampton became the chief nurse of the operating room when Johns Hopkins Hospital opened in 1889.[5] When "in the winter of 1889 or 1890" she developed a skin reaction to mercuric chloride that was used for asepsis, William Halsted, soon-to-be her husband, asked the Goodyear Rubber Company to produce thin rubber gloves for her protection.[5] In 1894 Halsted implemented the use of sterilized medical gloves at Johns Hopkins.[6][7] However, the first modern disposable glove was invented by Ansell Rubber Co. Pty. Ltd. in 1965.[8][9][10]
They based the production on the technique for making condoms.[11] These gloves have a range of clinical uses ranging from dealing with human excrement to dental applications.[citation needed]
Criminals have also been known to wear medical gloves during commission of crimes. These gloves are often chosen because their thinness and tight fit allow for dexterity. However, because of the thinness of these gloves, fingerprints may actually pass through the material as glove prints, thus transferring the wearer's prints onto the surface touched or handled.[12]
The participants of the Watergate burglaries infamously wore rubber surgical gloves in an effort to hide their fingerprints.[13]
Industry
[edit]In 2020, the market for medical gloves had a value of more than USD 10.17 billion and, with growing demand (especially in developing countries), is expected to grow by 9.2 per cent per year until 2028.[14] The majority of medical gloves are manufactured in South East Asia, with Malaysia alone accounting for about three quarters of global production in 2020.[15]
Labour rights violations
[edit]There have been several investigations in factories in Malaysia, Thailand and Sri Lanka that documented severe violations of human and labour rights. Both in Malaysia and Thailand migrants represent the majority of workers in hard physical labour. They are frequently recruited by specialized agencies in their less affluent home countries such as Nepal and are often charged with high recruitment fees forcing them into debt bondage. There are documented cases in which employees' passports were withheld by their employers leaving them especially vulnerable to exploitation.[16][17] In 2010, for instance, Swedwatch, a Swedish labour right NGO examining a Malaysian factory, reported that most employees were working 12 hours per day seven days a week without overtime pay or payslip, harassment of workers by the management, safety deficits and poor hygienic conditions in employee housing.[18][16] Reacting to these findings, from October 2019 to March 2020, the US Department of Labor listed medical gloves produced in Malaysia on the List of Goods Produced by Child Labor or Forced Labor and temporarily banned the import of gloves produced by the Malaysian company Top Glove, the world's largest manufacturer at the time.[19][20]
Sizing
[edit]Generally speaking, examination gloves are sized in XS, S, M and L. Some brands may offer size XL. Surgical gloves are usually sized more precisely since they are worn for a much longer period of time and require exceptional dexterity. The sizing of surgical gloves are based on the measured circumference around the palm (excluding the thumb) in inches, at a level slightly above the thumb's sewn. Typical sizing ranges from 5.5 to 9.0 at an increment of 0.5. Some brands may also offer size 5.0. First-time users of surgical gloves may take some time to find the right size and brand that suit their hand geometry the most.[21] People with a thicker palm may need a size larger than the measurement and vice versa. Sizing should be one of the first thing to look for. Dexterity is essential for every worker and wearing the wrong size of glove can have a huge impact on someone's work. Wearing the right size of glove can also increase comfort, which can influence workers to wear their assigned PPE.[22]
Research on a group of American surgeons found that the most common surgical glove size for men is 7.0, followed by 6.5; and for women 6.0 followed by 5.5.[23]
Powdered gloves
[edit]To facilitate donning of gloves, powders have been used as lubricants. Early powders derived from pines or club moss were found to be toxic.[24] Talcum powder was used for decades but linked to postoperative granuloma and scar formation. Corn starch, another agent used as lubricant, was also found to have potential side effects such as inflammatory reactions and granuloma and scar formation.[24][25]
Elimination of powdered medical gloves
[edit]With the availability of non-powdered medical gloves that were easy to don, calls for the elimination of powdered gloves became louder. By 2016, healthcare systems in Germany and the United Kingdom had eliminated their use.[24] In March 2016, the United States Food and Drug Administration (FDA) issued a proposal to ban their medical use[26] and on December 19, 2016 passed a rule banning all powdered gloves intended for medical use.[27] The rule became effective on January 18, 2017.[28]
Powder-free medical gloves are used in medical cleanroom environments, where the need for cleanliness is often similar to that in a sensitive medical environment.[29]
Chlorination
[edit]To make them easier to don without the use of powder, gloves can be treated with chlorine. Chlorination affects some of the beneficial properties of latex, but also reduces[30] the quantity of allergenic latex proteins.[31]
Polymer coating
[edit]On the market, it is a wide range of applications for polymer coatings in the market. Most of the current disposable gloves are powdered. These coatings include several polymers: silicone, acrylic resins, and gels that make gloves easier to wear. This process is currently used in nitrile gloves and latex gloves.[32]
Alternatives to latex
[edit]
Due to the increasing rate of latex allergy among health professionals,[33] and in the general population, gloves made of non-latex materials such as polyvinyl chloride, nitrile rubber, or neoprene have become widely used. Chemical processes may be employed to reduce the amount of antigenic protein in Hevea latex, resulting in alternative natural-rubber-based materials such Vytex Natural Rubber Latex. However, non-latex gloves have not yet replaced latex gloves in surgical procedures, as gloves made of alternative materials generally do not fully match the fine control or greater sensitivity to touch available with latex surgical gloves.[citation needed] (High-grade isoprene gloves are the only exception to this rule, as they have the same chemical structure as natural latex rubber. However, fully artificial polyisoprene—rather than "hypoallergenic" cleaned natural latex rubber[34]—is also the most expensive natural latex substitute available.[35]) Other high-grade non-latex gloves, such as nitrile gloves, can cost over twice the price of their latex counterparts, a fact that has often prevented switching to these alternative materials in cost-sensitive environments, such as many hospitals.[citation needed] Nitrile is more resistant to tearing than natural latex, and is more resistant to many chemicals.[36] Sulfur compounds used as accelerants to cure nitrile can speed the tarnishing process in silver, so accelerant-free nitrile or other gloves must be used when handling objects made of these metals when this is not acceptable.[36]
Double gloving
[edit]Double gloving is the practice of wearing two layers of medical gloves to reduce the danger of infection from glove failure or penetration of the gloves by sharp objects during medical procedures. Surgeons double glove when operating on individuals bearing infectious agents such as HIV and hepatitis, and to better protect patients against infections possibly transmitted by the surgeon. A systematic review of the literature has shown double gloving to offer significantly more protection against inner glove perforation in surgical procedures compared to the use of a single glove layer. But it was unclear if there was better protection against infections transmitted by the surgeon.[37] Another systematic review studied if double gloving protected the surgeon better against infections transmitted by the patient. Pooled results of 12 studies (RCTs) with 3,437 participants showed that double gloving reduced the number of perforations in inner gloves with 71% compared to single gloving. On average ten surgeons/nurses involved in 100 operations sustain 172 single gloves perforations but with double gloves only 50 inner gloves would be perforated. This is a considerable reduction of the risk.[38]
In addition, cotton gloves can be worn under the single-use gloves to reduce the amount of sweat produced when wearing these gloves for a long period of time. These under gloves can be disinfected and used again.[39]
See also
[edit]References
[edit]- ^ "Medical Gloves and Gowns". FDA. Archived from the original on 2009-05-13. Retrieved 2010-03-10.
One or more of the preceding sentences incorporates text from this source, which is in the public domain.
- ^ "Glove manufacturing". Ansell.eu. Archived from the original on 2011-10-04. Retrieved 2012-12-14.
- ^ "Personal Protective Equipment FAQ". Centers for Disease Control and Prevention. Archived from the original on 2013-05-16. Retrieved 2013-06-08.
- ^ "Glove Use Information Leaflet" (PDF). Archived (PDF) from the original on 2017-08-30. Retrieved 2022-03-28.
- ^ a b S. Robert Lathan (2010). "Caroline Hampton Halsted: the first to use rubber gloves in the operating room". Proc (Bayl Univ Med Cent). 23 (4): 389–92. doi:10.1080/08998280.2010.11928658. PMC 2943454. PMID 20944762.
- ^ "Hopkins Ceases Use Of Latex Gloves During Surgery". WJZ-TV. January 15, 2008. Archived from the original on October 11, 2008. Retrieved 2010-03-03.
- ^ "Rubber Gloves". Johns Hopkins Hospital. January 14, 2008. Archived from the original on 2008-12-19. Retrieved 2010-03-03.
- ^ Brown, Walter (December 12, 2016). "The History of Disposable Gloves". Blog.ammex.com. Archived from the original on April 26, 2021. Retrieved March 24, 2021.
- ^ "Ansell – Our history". Ansell.com. Archived from the original on 2021-03-19. Retrieved 2021-03-24.
- ^ "Surgeon's glove having improved donning properties". Patents.google.com. Archived from the original on 6 April 2022. Retrieved 25 October 2021.
- ^ "100 Years of Australian Innovation – latex gloves". Archived from the original on 2009-10-15. Retrieved 2010-03-07.
- ^ Robert Ramotowski (2012-10-18). Lee and Gaensslen's Advances in Fingerprint Technology, Third Edition. CRC Press. pp. 171–. ISBN 978-1-4200-8837-3.
- ^ "Watergate". Spartacus.Schoolnet.co.uk. Archived from the original on 2012-12-03. Retrieved 2012-12-14.
- ^ "Disposable Gloves Market Trends & Growth Report, 2020–2028". Grandviewresearch.com. Archived from the original on 2021-04-20. Retrieved 2021-04-21.
- ^ Linderman, Ulket; Mendoza, Martha (2020-03-24). "Malaysia makes 3 out of 4 of the world's medical gloves. The factories are operating at half capacity". Chicago Tribune. Archived from the original on 2021-04-21. Retrieved 2021-04-21.
- ^ a b Bhutta, Mahmood; Santhakumar, Arthy (2016). In good hands – Tackling labour rights concerns in the manufacture of medical gloves. British Medical Association.
- ^ "USA: Dep't of Labor adds Malaysian rubber gloves to list of forced labour-produced goods following revelations of migrant worker abuse". Business & Human Rights Resource Centre (in Spanish). Archived from the original on 2021-04-21. Retrieved 2021-04-21.
- ^ Swedwatch (2010). Papyrus Sweden ABs purchase of nitrile gloves from Malaysia. Stockholm.
{{cite book}}: CS1 maint: location missing publisher (link) - ^ Zsombor, Peter (2019-10-11). "US Ban on Malaysian Glove Maker Highlights "Systemic" Labor Abuse". VOA News. Archived from the original on 2021-04-21. Retrieved 2021-04-21.
- ^ "U.S. lifts ban on Malaysian medical glove maker amid shortage". Reuters. 2020-03-25. Archived from the original on 2021-04-21. Retrieved 2021-04-21.
- ^ "Surgical Gloves Size Chart". Surgicalglove.net. Archived from the original on 2017-05-14. Retrieved 2017-05-21.
- ^ "How To Choose Your Gloves Wisely?". Neobexmedical.com. 5 April 2021. Archived from the original on 2021-04-27. Retrieved 2021-04-27.
- ^ Berguer R, R; Hreljac, A (2004). "The relationship between hand size and difficulty using surgical instruments: a survey of 726 laparoscopic surgeons". Surgical Endoscopy. 18 (3): 508–512. doi:10.1007/s00464-003-8824-3. PMID 15100896. S2CID 24116170.
- ^ a b c Robert Lowes (March 21, 2016). "FDA Proposes Ban of Powdered Medical Gloves". Medscape. Archived from the original on September 23, 2017. Retrieved March 22, 2016.
- ^ Lambert, B. J.; Tang, F.-W.; Rogers, W. J. (2001). Polymers in Medical Applications. iSmithers Rapra Publishing. p. 77. ISBN 978-1-85957-259-7.
- ^ "FDA proposes ban on most powdered medical gloves". Fda.gov. March 21, 2016. Archived from the original on April 25, 2019. Retrieved December 16, 2019.
- ^ "FDA bans most powdered gloves". Ada.org. Archived from the original on 25 October 2021. Retrieved 25 October 2021.
- ^ "Federal Register :: Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove". Archived from the original on 2018-01-11. Retrieved 2018-01-11.
- ^ Handbook on Medical and Surgical Disposable Products. Niir Project Consultancy Services. 2014. p. 43. ISBN 978-93-81039-28-1.
- ^ "User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide". Food and Drug Administration. Archived from the original on 2016-09-06. Retrieved 2017-11-13.
- ^ Medical Glove Powder Report (Report). U.S. Food and Drug Administration. September 1997. Archived from the original on May 12, 2016. Retrieved June 2, 2016.
- ^ Lan, Jian. "Production Process: Power Gloves VS Powder Free Gloves". YICHANG. Archived from the original on 2021-11-12. Retrieved 2021-11-12.
- ^ Brehler R, Kütting B (2001). "Natural Rubber Latex Allergy A Problem of Interdisciplinary Concern in Medicine". Archives of Internal Medicine. 161 (8). JAMA: 1057–1064. doi:10.1001/archinte.161.8.1057. PMID 11322839. Archived from the original on 9 February 2020. Retrieved 10 May 2020.
- ^ "User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide". Food and Drug Administration. Archived from the original on 2012-11-03. Retrieved 2012-12-14.
- ^ "Polyisoprene Surgical Gloves". SurgicalGlove.net. Archived from the original on 2008-09-18. Retrieved 2012-12-14.
- ^ a b "Acrobat Accessibility Report" (PDF). Nps.gov. Archived (PDF) from the original on 19 June 2015. Retrieved 25 October 2021.
- ^ Tanner, J; Parkinson, H (2006). "Double gloving to reduce surgical cross-infection". The Cochrane Database of Systematic Reviews. 2006 (3) CD003087. doi:10.1002/14651858.CD003087.pub2. PMC 7173754. PMID 16855997.
- ^ Mischke, C; Verbeek, J (2014). "Gloves, extra gloves or special types of gloves for preventing percutaneous exposure injuries in healthcare personnel". The Cochrane Database of Systematic Reviews. 2014 (3) CD009573. doi:10.1002/14651858.CD009573.pub2. PMC 10766138. PMID 24610769.
- ^ Kramer, Axel; Assadian, Ojan (2016-01-12). "Indications and the requirements for single-use medical gloves". GMS Hygiene and Infection Control. 11: Doc01. doi:10.3205/dgkh000261. ISSN 2196-5226. PMC 4714734. PMID 26816673.
Medical glove
View on GrokipediaMedical gloves are disposable personal protective equipment designed as thin, elastic coverings for the hands to prevent the transmission of microorganisms during medical procedures, safeguarding both healthcare workers and patients as integral components of infection control protocols. [1]
They encompass sterile surgical gloves for invasive operations requiring asepsis and non-sterile examination gloves for routine clinical contacts involving potential exposure to bodily fluids or pathogens. [1][2]
Principal materials include natural rubber latex for superior tactile sensitivity and elasticity, alongside synthetic alternatives such as nitrile, polyvinyl chloride, and polyurethane, which offer enhanced chemical resistance and reduced allergenicity. [1][3]
Originating in the 1890s when surgeon William Halsted commissioned rubber gloves to shield his nurse from mercuric chloride dermatitis, their adoption accelerated with recognition of antisepsis principles, transitioning from reusable to predominantly single-use formats by the mid-20th century. [4][5]
While empirically effective in curtailing healthcare-associated infections, medical gloves have provoked controversies centered on latex protein-induced type I hypersensitivity reactions, spurring regulatory prohibitions on powdered variants—which facilitated aerosolized allergen spread—and proliferation of powder-free and non-latex substitutes. [6][7][8]
In jurisdictions like the United States, the Food and Drug Administration oversees them as Class I reserved devices, mandating 510(k) clearance, acceptable quality limits for pinhole defects, and compliance with standards for physical integrity and biocompatibility to ensure reliable barrier function. [1]
History
Invention and Early Use
In the late 1880s, surgeon William Stewart Halsted at Johns Hopkins Hospital in Baltimore, Maryland, sought to protect his chief scrub nurse, Caroline E. Hampton, from severe dermatitis caused by repeated exposure to a mercuric chloride disinfectant solution used for hand washing during surgeries.[5] Halsted commissioned the Goodyear Rubber Company to produce thin, flexible rubber gloves molded from plaster casts of Hampton's hands, marking the first documented creation of purpose-built medical gloves in 1889.[9] These early gloves, made from vulcanized rubber rather than natural latex, were approximately 0.025 inches thick and designed primarily for chemical protection, though Halsted recognized their potential to reduce surgical site infections amid emerging antiseptic practices.[4] Hampton began wearing the gloves during operations in 1889, reporting improved manual dexterity and sensitivity compared to bare hands coated in the irritant solution, which led to additional pairs being ordered for other operating room staff.[5] Halsted himself adopted gloves sporadically at first, primarily for specific procedures, but by around 1896, he routinely used custom-fitted pairs made from bronze hand casts sent to Goodyear, integrating them into his aseptic technique influenced by Joseph Lister's principles.[10] Early adoption remained limited to Halsted's team at Johns Hopkins, where they facilitated delicate tissue handling without compromising sterility, though widespread surgeon resistance persisted due to perceived loss of tactile feedback and the prevailing view that bare hands sufficed under rigorous washing.[9] By the early 1890s, select surgeons like Joseph C. Bloodgood at Johns Hopkins extended glove use to hernia repairs, observing markedly lower postoperative infection rates, which provided empirical impetus for gradual acceptance beyond chemical protection.[9] Hampton and Halsted married in 1890, and her role in pioneering glove use underscored the practical origins of this innovation in addressing occupational hazards rather than purely germ theory-driven sterility.[5] These initial rubber prototypes laid the groundwork for medical gloves, transitioning from ad hoc solutions to standardized surgical tools over the subsequent decades.[4]Adoption Amid Asepsis Debates
In 1890, American surgeon William Stewart Halsted introduced thin rubber gloves into surgical practice at Johns Hopkins Hospital, initially to protect the hands of his scrub nurse, Caroline Hampton, from severe contact dermatitis caused by prolonged exposure to mercuric chloride and alcohol disinfectants during antisepsis procedures.[5] [11] Halsted commissioned the Goodyear Rubber Company to produce two pairs of gloves, marking the first documented use of such barriers in the operating room, though their adoption occurred against a backdrop of ongoing debates between antisepsis—chemical disinfection pioneered by Joseph Lister in the 1860s—and emerging aseptic techniques emphasizing sterility without antiseptics.[12] [13] The introduction of gloves intensified discussions on asepsis, as many surgeons prioritized manual techniques like rigorous hand scrubbing and instrument boiling over mechanical barriers, viewing gloves as potentially impairing tactile sensitivity and complicating surgical dexterity.[14] In German-speaking medical communities during the 1890s, this tension manifested as a explicit controversy between "manual control" strategies—relying on surgeon skill and hygiene discipline—and "technological control" via gloves, with critics arguing that gloves could foster complacency in aseptic habits while proponents, including Halsted, later observed reduced postoperative infection rates attributable to the barrier's role in preventing microbial transfer from skin flora.[15] [16] Halsted himself acknowledged in later reflections that gloves enhanced precision and sterility, but resistance persisted, with glove usage among surgeons remaining low at approximately 5% by the early 1890s.[17] Empirical evidence began shifting opinions; for instance, in 1893, surgeon Joseph C. Bloodgood at Johns Hopkins adopted gloves selectively for hernia operations and reported a sharp decline in surgical site infections, attributing this to the gloves' ability to maintain a sterile field despite imperfect hand preparation.[9] By 1900, adoption had increased to about 28% globally, driven by accumulating case reports of lower sepsis rates in gloved procedures, though full consensus lagged due to variability in rubber quality—early gloves were thick and cumbersome—and entrenched preferences for unmediated touch in delicate operations.[18] These debates underscored a broader transition in surgical philosophy toward layered precautions, where gloves complemented rather than replaced aseptic fundamentals, ultimately proving their value through reduced morbidity data rather than theoretical advocacy alone.[16]Post-WWII Standardization and Mass Production
Following World War II, surgical glove usage expanded rapidly as wartime experiences demonstrated their effectiveness in minimizing infections, with approximately 75% of surgeons employing them during procedures. The end of global rubber shortages enabled scaled manufacturing, culminating in the introduction of the first automated glove production machine in 1946, which shifted from labor-intensive hand-dipping to efficient mass output capable of meeting surging hospital demands.[18][19] By the 1950s, gloves had transitioned from optional to routine equipment in high-volume surgical environments, including military hospitals transitioning to civilian care, driven by aseptic protocol refinements and increased procedure volumes. Reusable latex gloves, autoclaved between uses, dominated but faced challenges with durability and contamination risks, prompting innovations in thinner, more flexible designs.[19] Mass production reached a milestone in 1964 with Ansell Rubber Company's launch of the first disposable sterile latex medical gloves, processed via gamma irradiation for reliable sterilization without reuse. This development reduced cross-contamination hazards and supported standardization in sizing, thickness, and puncture resistance, aligning with emerging industry practices for consistent quality across suppliers.[20][21]Materials and Types
Natural Latex Gloves
Natural latex gloves are manufactured from the sap of the Hevea brasiliensis rubber tree, primarily sourced from plantations in Thailand and Indonesia, which supply the majority of global natural rubber latex.[22] The latex is a colloidal suspension of cis-1,4-polyisoprene, processed through coagulation, milling, and compounding with vulcanizing agents like sulfur to form thin, elastic films suitable for medical use.[3] These gloves have historically served as the benchmark for surgical and examination applications due to their material properties, though their prevalence has declined with the rise of synthetic alternatives.[22] The material exhibits superior elasticity and tensile strength, with elongation at break exceeding 600% in typical formulations, enabling a snug fit that mimics skin without restricting dexterity.[23] This provides exceptional tactile sensitivity for procedures requiring fine motor control, such as microsurgery, outperforming many synthetics in puncture resistance under low-strain conditions (ASTM D3578 standards report failure rates below 2.5 per 1,000 gloves for high-quality latex).[22] Additionally, natural latex is biodegradable under industrial composting conditions, decomposing via microbial action on polyisoprene chains, which contrasts with persistent synthetic polymers.[24] Despite these benefits, natural latex contains over 200 proteinaceous allergens, including Hev b 1 through Hev b 6, which can trigger type I hypersensitivity reactions via IgE-mediated mast cell degranulation.[25] Latex allergy prevalence among healthcare workers averages 9.7%, with sensitization rates up to 12.4% as of 2014 data, manifesting as contact urticaria, rhinitis, or anaphylaxis in sensitized individuals exposed repeatedly.[26] Processing reduces soluble proteins to below 50 μg/dm² in powder-free variants per ASTM D6124, mitigating but not eliminating risk, as residual allergens persist in the vulcanized matrix.[27] Chemical additives during manufacturing, such as accelerators (e.g., thiurams), may also provoke type IV delayed hypersensitivity dermatitis.[28] In contemporary healthcare, natural latex gloves retain niche utility in non-allergic settings for their "second-skin" dexterity, but regulatory shifts— including FDA bans on powdered latex gloves in 2016—have accelerated adoption of low-allergen or synthetic options to curb occupational sensitization.[22] Usage statistics indicate a drop from dominance pre-2000 to under 20% of U.S. surgical gloves by 2020, driven by allergy concerns rather than inherent material flaws.[26] Empirical testing confirms latex's barrier efficacy against bloodborne pathogens (viral penetration <1.5% in glove juice assays), yet its vulnerability to oils and solvents limits versatility compared to nitrile.[29]Synthetic Materials (Nitrile, Vinyl, Neoprene)
Synthetic medical gloves, composed of materials such as nitrile, vinyl, and neoprene, serve as latex alternatives to mitigate type I hypersensitivity reactions, which affect approximately 10-17% of healthcare workers exposed to natural rubber latex proteins.[3] These polymers provide barrier protection without eliciting allergic responses, though their adoption accelerated in the mid-1990s amid rising latex allergy reports, with nitrile prototypes patented in 1991 and commercially available by that decade's end.[30] Unlike latex, synthetics lack natural elasticity but excel in chemical resistance and durability for non-sterile and sterile applications, per ASTM D6319 standards for examination gloves requiring minimum elongation of 500% and tensile strength of 14 MPa.[31] Nitrile gloves, derived from acrylonitrile-butadiene rubber, demonstrate superior puncture resistance compared to vinyl, enduring forces approximately 20-30% higher before breach in standardized tests, making them suitable for high-risk procedures involving sharps.[32] They offer excellent resistance to oils, acids, and solvents, with tensile strengths often exceeding 20 MPa, outperforming latex in chemical permeation tests under EN 374 standards.[33] Drawbacks include reduced flexibility at low temperatures and higher production costs, roughly 20-50% more than vinyl, limiting use in budget-constrained settings.[34] Nitrile's hypoallergenic profile and dexterity, akin to latex, positioned it as the dominant synthetic by the 2010s, capturing over 60% of the exam glove market due to consistent barrier integrity against bloodborne pathogens.[35] Vinyl gloves, fabricated from polyvinyl chloride (PVC) plasticized with phthalates, provide economical barrier protection for low-hazard tasks like patient handling or food service, costing 30-50% less than nitrile equivalents.[36] However, their inferior puncture resistance—failing at forces 40-50% lower than nitrile—and limited elasticity result in higher permeation rates for biohazards, rendering them unsuitable for invasive procedures per CDC guidelines favoring higher-integrity materials.[34] Vinyl's chemical resistance is modest, degrading under exposure to lipids or alcohols, and it exhibits poorer tactile sensitivity due to thicker, looser construction, with elongation typically below 300%.[24] Despite these limitations, vinyl remains prevalent in non-medical disposable uses, adopted widely since the 1960s for its stability and lack of protein allergens.[37] Neoprene gloves, based on polychloroprene, approximate latex's stretch and comfort with elongation up to 600%, offering robust resistance to abrasion, ozone, and moderate chemicals while remaining latex-free.[38] They provide thermal insulation and flexibility superior to nitrile, ideal for cold environments or prolonged wear, but exhibit lower puncture resistance than nitrile, with failure thresholds 10-20% reduced in comparative durability assessments.[39] Higher manufacturing costs and potential degradation from strong oxidizers limit neoprene's medical adoption to specialized applications like chemotherapy handling, where its solvent resistance exceeds vinyl but trails nitrile in oil compatibility.[40] Durability studies confirm neoprene matches latex in abrasion resistance, supporting its use in scenarios demanding balanced mechanical properties over maximal puncture fortitude.[39]Powdered Versus Powder-Free Variants
Powdered medical gloves incorporate absorbable powders, typically cornstarch, applied during manufacturing to facilitate donning and doffing by reducing surface tackiness and enhancing user comfort.[41] These powders bind to latex proteins in natural rubber gloves, enabling easier handling but introducing risks when particles become airborne or contaminate surgical sites.[42] In contrast, powder-free variants eliminate such powders, relying instead on manufacturing techniques like chlorination, polymer coating, or inline molding to achieve similar slipperiness without residual particulates.[43] The primary distinction arises from health risks associated with powdered gloves, particularly in latex-containing products. Cornstarch powder acts as a carrier for allergenic latex proteins, which can aerosolize during glove use, leading to respiratory sensitization, asthma, and anaphylactic reactions in sensitized individuals, including healthcare workers and patients.[44] [42] Studies have demonstrated that this airborne exposure correlates with the sharp rise in latex allergies since the 1980s, coinciding with the industry shift from talc—which settles quickly—to lighter cornstarch powders.[44] Powder-free gloves mitigate these issues by removing the powder vector, significantly lowering the incidence of protein-induced allergies; for instance, they pose reduced risk even for those with mild latex sensitivity.[43] Additionally, powdered gloves can provoke inflammatory responses, granuloma formation, and wound adhesions in patients due to powder residues, with evidence showing higher rates of post-surgical complications compared to powder-free alternatives.[45] [41] Regulatory responses reflect the imbalance between limited benefits and substantial hazards. In the United States, the Food and Drug Administration (FDA) issued a final rule on December 19, 2016, banning powdered surgeon's gloves, powdered patient examination gloves, and absorbable powders for internal use, effective January 18, 2017, after determining that adverse events—such as allergic reactions and surgical inflammation—outweighed donning ease, especially with viable powder-free substitutes available.[1] [41] This followed decades of evidence accumulation, including a 1997 FDA review that initially deferred action due to supply concerns but later prioritized safety as markets adapted.[46] Similar restrictions have emerged globally, with many regions phasing out powdered variants amid allergy epidemics, though enforcement varies; for example, the European Union has aligned with powder-free standards through medical device regulations emphasizing risk minimization.[47]| Aspect | Powdered Gloves | Powder-Free Gloves |
|---|---|---|
| Donning Ease | High, due to powder lubrication[41] | Comparable via chlorination or coatings; no residue[43] |
| Allergy Risk | Elevated; powder carries airborne latex allergens[42] [44] | Low; eliminates protein carrier[43] |
| Surgical Complications | Risk of inflammation, granulomas, adhesions[45] | Minimal; cleaner barrier[41] |
| Regulatory Status (US) | Banned since 2017[1] | Standard; preferred for compliance[48] |
Manufacturing and Industry
Production Processes and Technologies
Medical gloves are primarily produced through a dipping process using hand-shaped formers mounted on automated conveyor lines, which allows for high-volume output while shaping the material to mimic human hands.[49] This method, common to both natural latex and synthetic variants like nitrile, involves sequential dips in coagulants and polymer compounds to build thickness, followed by curing and finishing steps. Production lines typically operate continuously, with capacities exceeding millions of pairs per day in large facilities, driven by demand spikes such as those during the COVID-19 pandemic that necessitated rapid scaling.[50] For natural latex gloves, the process begins with compounding centrifuged latex from Hevea brasiliensis trees, mixed with vulcanizing agents, accelerators like zinc diethyl dithiocarbamate, antioxidants, and stabilizers to achieve desired elasticity and strength.[51] Formers—porcelain or ceramic molds—are cleaned via acid rinse and hot water immersion to remove residues, then dipped in a coagulant solution of calcium nitrate in alcohol or water, which adheres the latex upon subsequent immersion.[52] The formers are dried, dipped multiple times in the latex bath (with dwell time controlling thickness, typically 0.1-0.2 mm for exam gloves), and undergo leaching in hot water baths at 60-80°C to extract residual proteins and chemicals, reducing allergenicity. Vulcanization follows in heated tunnels at 100-120°C for 1-2 minutes, crosslinking sulfur bridges for durability. Cuffs are beaded by rolling over a blade, and gloves are stripped via automated mandrels or air jets, yielding inversion.[49][53] Synthetic nitrile gloves employ a similar dipping sequence but start with synthetic polybutadiene-acrylonitrile latex produced via emulsion polymerization of butadiene and acrylonitrile monomers, offering puncture resistance superior to latex without natural proteins.[54] Formers undergo coagulant dipping, followed by immersion in nitrile butadiene rubber (NBR) latex, with multiple layers for thickness buildup; coagulant concentration and speed dictate uniformity. Leaching removes unreacted monomers and accelerators, while vulcanization at elevated temperatures with peroxide or sulfur systems enhances tensile strength to over 14 MPa. Powder-free variants receive polymer coating (e.g., silicone-based) or chlorination (exposing to chlorine gas or hypochlorite solution) to modify surface for easy donning without cornstarch, the latter process etching the inner surface microscopically.[55][56] Advanced technologies integrate inline monitoring, such as refractometers for coagulant density control and conductivity sensors for leaching efficacy, minimizing defects like pinholes (limited to <2.5 per 100 cm² per ASTM D6124). Automated optical inspection systems detect tears or thin spots via machine vision, with rejection rates under 1% in efficient lines. Recent innovations include robotic handling for sterile surgical gloves and biodegradable additives in nitrile formulations to accelerate decomposition, though scalability remains limited as of 2023.[49][57] Post-production, gloves undergo tensile testing (ASTM D6319 requiring >12 MPa elongation), air inflation for leaks, and packaging in cleanrooms with ethylene oxide or gamma irradiation for sterility where required.[50]Global Supply Chains and Market Dynamics
The global production of medical gloves is heavily concentrated in Southeast Asia, with Malaysia, Thailand, and Indonesia serving as primary manufacturing hubs due to abundant natural rubber resources and established industrial infrastructure.[58] Malaysia alone accounts for a significant portion of latex glove output, supported by major firms such as Top Glove Corporation, Hartalega Holdings, Kossan Rubber Industries, and Supermax Corporation, which dominate export volumes.[59] China contributes substantially to disposable glove supply, producing approximately 90 billion units annually and holding over 20% of the global market share, leveraging economies of scale and lower labor costs.[60] This regional dominance stems from historical investments in automation and proximity to raw material sources, though it exposes supply chains to localized risks such as labor strikes or natural disasters. Raw material procurement forms a critical vulnerability in the supply chain, with natural latex derived primarily from hevea rubber trees cultivated in Southeast Asia, while synthetic alternatives like nitrile rely on petrochemical feedstocks including acrylonitrile and butadiene, often sourced from global energy markets.[61] Disruptions in these inputs, including volatile rubber prices and petrochemical shortages exacerbated by geopolitical tensions or energy crises, have periodically constrained production capacity.[62] The COVID-19 pandemic illustrated these fragilities, triggering widespread shortages from panicked stockpiling, export restrictions in producer nations, and overwhelmed logistics, which revealed over-dependence on a handful of suppliers and prompted temporary U.S. federal investments in domestic manufacturing, such as $70 million allocated to facilities like Renco Diagnostics.[63][64] Market dynamics reflect sustained post-pandemic demand driven by heightened infection control protocols, an aging global population, and regulatory shifts favoring powder-free and synthetic gloves to mitigate latex allergies.[65] The global medical gloves market was valued at approximately USD 20.52 billion in 2024, projected to expand to USD 44.64 billion by 2032 at a compound annual growth rate (CAGR) of 10.2%, fueled by healthcare infrastructure growth in emerging economies and increased non-medical applications in food handling and cleanrooms.[65] Key players have responded with capacity expansions and diversification into nitrile production, yet persistent challenges include counterfeit influxes from unregulated Asian facilities and rising import tariffs, such as anticipated U.S. duties in 2025 that could elevate costs by redirecting trade flows.[66] Efforts to enhance resilience, including U.S. initiatives to reduce reliance on Chinese imports—which exceed 50% for certain critical supplies—have spurred limited onshoring, though high capital barriers and energy costs hinder scalability outside Asia.[67][68]Labor Practices, Costs, and Ethical Challenges
The medical glove industry, dominated by production in Southeast Asia—particularly Malaysia, Thailand, and China—relies heavily on low-wage migrant labor from countries such as Bangladesh, Nepal, and India to maintain cost competitiveness. Workers, often numbering in the hundreds of thousands across major factories, face documented conditions including excessive recruitment fees leading to debt bondage, passport confiscation by employers or agents, overcrowded dormitories, and forced overtime exceeding 60 hours per week, sometimes up to 18 hours daily during peak demand periods like the COVID-19 pandemic. These practices have been identified as indicators of forced labor under International Labour Organization conventions, with Malaysia's rubber glove sector specifically listed by the U.S. Department of Labor as producing goods via forced and child labor as of 2020.[69] [70] [71] A prominent example involves Top Glove Corporation, the world's largest medical glove manufacturer, which in 2020 faced a U.S. Customs and Border Protection Withhold Release Order banning imports from its facilities due to evidence of debt bondage, excessive deposits on worker passports, and withholding of wages—practices affecting over 30,000 migrant workers across its 48 Malaysian factories. The ban, imposed on July 15, 2020, and expanded in 2021 to cover more subsidiaries, disrupted global supply chains until lifted on September 10, 2021, following remediation efforts including repayment of recruitment debts totaling millions of dollars and improved housing. Independent audits and reports from labor rights groups, however, noted persistent issues such as inadequate sanitation and retaliation against complaining workers, exacerbated by pandemic-driven production surges that worsened exploitation without proportional wage increases.[72] [73] [74] Labor costs constitute a significant but unquantified portion of overall production expenses, estimated to comprise part of the 15-20% allocated to operating costs beyond raw materials (which account for 45-70% depending on material type like nitrile butadiene rubber). In Malaysia, average monthly wages for migrant glove workers hover around $200-300 USD, far below living wage benchmarks, enabling unit costs as low as $0.02-0.05 per disposable glove and facilitating market dominance by Asian producers supplying 70% of global demand. This cost structure, driven by minimal regulatory enforcement and high worker turnover, has allowed rapid scaling—such as Top Glove's output doubling to 50 billion pairs annually by 2020—but at the expense of worker health, with reports of chemical exposure without adequate protective equipment and limited access to medical care.[75] [54] [76] Ethical challenges stem from supply chain opacity and weak enforcement of human rights due diligence, prompting calls from organizations like the British Medical Association for procurement policies mandating audits and ethical sourcing certifications. While some manufacturers have adopted voluntary codes, systemic reliance on third-party recruiters perpetuates debt bondage, with workers paying fees equivalent to 6-12 months' salary upfront, trapping them in cycles of indebtedness. Controversies extend to counterfeit gloves from unregulated Thai and Chinese facilities, where similar abuses occur amid poor traceability, raising risks of substandard products entering healthcare systems. Governments and buyers, including the UK's NHS, have faced criticism for indirect sourcing from implicated suppliers, highlighting tensions between cost-driven procurement and accountability.[77] [78] [79]Standards and Quality Assurance
Sizing, Fit, and Ergonomic Standards
Medical gloves are typically sized according to hand circumference measured around the palm just below the knuckles, excluding the thumb, with common designations ranging from extra small (XS) to extra large (XL).[80] For surgical gloves, numerical sizing is often used, such as 5–5.5 for XS, 6–6.5 for small, 7–7.5 for medium, 8–8.5 for large, and 9+ for XL, aligning with standardized hand measurements to ensure ambidextrous or handed fit.[81] Standards like ASTM D6319 for nitrile examination gloves and ASTM D3577 for rubber surgical gloves mandate consistent sizing for paired or individual gloves, specifying minimum dimensions such as palm width and length to accommodate user variability without explicit universal measurement protocols.[82][83] Fit requirements emphasize a snug yet non-restrictive profile to minimize slippage and bunching, with ISO 11193-1 and EN 455 standards requiring gloves to conform to hand contours for either hand use in examination variants, while surgical models may incorporate anatomical shaping for enhanced precision.[84] Proper fit reduces material stress points that could lead to tears, as verified through tensile and dimensional testing in ASTM protocols, which ensure uniformity in thickness and elongation across sizes.[85] Ergonomic standards prioritize dexterity preservation, with studies indicating that ill-fitting gloves exacerbate reductions in grip strength by up to 20–30% and impair fine motor tasks compared to bare hands.[86][87]| Glove Size | Approximate Palm Circumference (inches) | Typical Hand Length (inches) |
|---|---|---|
| XS | 6.5–7.0 | 6.0–6.5 |
| S | 7.0–7.5 | 6.5–7.0 |
| M | 7.5–8.5 | 7.0–7.5 |
| L | 8.5–9.5 | 7.5–8.0 |
| XL | 9.5–10.5 | 8.0+ |
Regulatory Testing for Integrity and Barriers
Regulatory testing for medical glove integrity evaluates the structural soundness of the glove to prevent breaches such as pinholes, tears, or leaks that could allow pathogen transmission or fluid permeation. In the United States, the Food and Drug Administration (FDA) classifies patient examination and surgeons' gloves as Class I reserved medical devices requiring 510(k) premarket notification, with mandatory testing for barrier integrity using visual examination for defects and the water leak test per ASTM D5151.[1] [92] [93] This test fills each sampled glove with 1000 mL of water, seals the cuff, inverts it, and applies massaging pressure for approximately 2 minutes to detect any leakage, ensuring the glove maintains watertight integrity under simulated use conditions.[94] [83] The FDA enforces quality through the Acceptable Quality Limit (AQL), a statistical sampling plan that determines the maximum allowable defect rate in a batch; for surgeons' gloves, the minimum acceptable AQL is 1.5 (1.5% defective units), while patient examination gloves require 2.5 AQL, reflecting higher scrutiny for invasive procedures.[92] Sampling follows ANSI/ASQ Z1.4 standards, with larger sample sizes for surgical gloves to account for critical risk.[95] In the European Union, EN 455-1 mandates a comparable watertight test for single-use medical gloves, applying an AQL of 1.5, with surgical gloves often tested to stricter manufacturer targets like 0.65 AQL for enhanced reliability.[96] [97] These limits derive from empirical data on perforation rates, prioritizing low false negatives in defect detection to uphold causal links between glove failures and infection risks.[83] Barrier performance testing extends beyond gross leaks to assess resistance to microbial and viral penetration, using methods like ASTM F1671, which employs the phi-X174 bacteriophage to simulate viral challenges under pressure differentials mimicking clinical exposure.[94] Complementary standards such as ASTM D3577 for surgical gloves and ASTM D6319 for nitrile examination gloves incorporate these alongside physical durability tests, including air inflation for visible flaws and tensile strength evaluation to prevent tearing.[94] [98] Internationally, ISO 11193-1 harmonizes leak detection with water or air methods, ensuring equivalence across regions while emphasizing empirical validation over theoretical models.[98] Non-compliance, often detected in post-market surveillance, has prompted FDA recalls, underscoring the tests' role in mitigating real-world failure modes like manufacturing defects.[99]| Glove Type | Standard/Regulation | Minimum AQL for Pinholes/Leaks |
|---|---|---|
| Surgeons' Gloves | FDA (21 CFR 800.20) | 1.5 |
| Patient Exam Gloves | FDA (21 CFR 800.20) | 2.5 |
| Single-Use Medical Gloves | EN 455-1 | 1.5 |
