Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft guidance document contact Subhas Malghan (OSEL) at 301-796-2548, or by e-mail at Subhas.email@example.com; or Sheila Murphey (ODE) at 301-796-6302, or by e-mail at firstname.lastname@example.org.
U.S. Department of Health and Human Services
Office of Science and Engineering Laboratories
Infection Control Devices Branch
Additional copies are available from the Internet. You may also send an e-mail request to email@example.com to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1704) to identify the guidance you are requesting.
Table of Contents
Draft Guidance for Industry, Clinical Laboratories and FDA Staff
Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder
This draft guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This draft guidance recommends use of a warning statement on labels for powdered medical gloves, specifically surgeon’s gloves (21 CFR 878.4460) and patient examination gloves (21 CFR 880.6250) (medical gloves that use powder).1 FDA is concerned about the potential adverse health effects from powdered medical gloves and is recommending that the labeling for medical gloves that use powder provide a warning related to those potential health effects.
FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This draft guidance applies to medical gloves that use powder, specifically surgeon’s gloves (21 CFR 878.4460) and patient examination gloves (21 CFR 880.6250) that use powder, 2 with the following product codes:
|Classification (21 CFR)||Product Code||Product Code Description|
|878.4460||KGO||Powdered latex surgeon’s gloves|
|878.4460||OPG||Powdered synthetic/non-latex surgeon's gloves|
|880.6250||OPB||Powdered polychloroprene patient examination glove|
|880.6250||OPD||Powdered nitrile patient examination glove|
|880.6250||OPE||Powdered latex patient examination glove|
|880.6250||OPF||Powdered vinyl patient examination glove|
FDA is issuing this draft guidance with labeling recommendations because of concerns that users and patients may not be aware of the potential adverse health effects associated with these devices. This draft guidance provides a recommended labeling warning intended to complement FDA’s 2008, “Guidance for Industry and FDA Staff - Medical Glove Guidance Manual” and FDA’s 2004, “Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove”. If this draft guidance is finalized, FDA will update these two glove-related guidances to reflect the labeling recommendations.
In 1997, FDA issued the “Medical Glove Powder Report” discussing the potential adverse health effects of medical glove powder, along with alternatives and current market information available at that time. Adverse health events reviewed by the Medical Glove Powder Report included (a) aerosolized powder on natural rubber latex (NRL) gloves carrying allergenic proteins as a cause of respiratory allergic reactions, (b) rhinitis, conjunctivitis and dyspnea, (c) respiratory problems, (d) granuloma formation, and (e) peritoneal adhesions. Since that time, there have been more studies regarding the risks related to medical glove powder. These clinical and laboratory studies published after 1997 indicate cornstarch glove powder affects wound healing, inflammation, adhesion formation, granulomatous peritonitis, respiratory function, as well as allergic responses.3-23 FDA has reviewed studies from clinics and hospitals that have converted completely to powder-free gloves, indicating reduction in allergy development and respiratory issues among health care workers.18,24-36 However, this has not been a universal finding.37
Epidemiology studies comparing the economic and adverse health events in healthcare settings before and after conversion to powder-free gloves have limitations. However, the preponderance of evidence suggests that use of low protein powder-free gloves significantly reduces occupational asthma and incidence of individuals developing allergies to NRL.18,26-36
FDA is issuing this draft guidance with a recommended warning statement for powdered medical gloves, informing users of the potential adverse health effects from these devices, including foreign body reaction, formation of granulomas, and peritoneal adhesion, especially with multiple surgeries. The warning should also include information on increases in respiratory ailments, and the development of irritant dermatitis or Type IV allergy when glove powder is used on NRL gloves. In addition, the warning should state that powder used on NRL medical gloves can serve as a carrier for airborne allergenic natural rubber latex proteins . Manufacturers who choose to use a warning other than the one provided below should ensure that the labeling addresses the risks inherent to powdered gloves.
Because of the concerns related to the potential adverse health effects from use of medical gloves that use powder and to ensure compliance with section 502 of the Federal Food, Drug, and Cosmetic Act and 21 CFR 801.5, FDA recommends that labeling for medical gloves that use powder include the following warning statement:
Warning: Powdered gloves may lead to foreign body reactions and the formation of granulomas in patients. In addition, the powder used on gloves may contribute to the development of irritant dermatitis and Type IV allergy, and on latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users.
FDA recommends that manufacturers of powdered gloves include this change to their product labeling no later than six months after issuance of final guidance based on this draft, and sooner if possible.
- For more information on “medical gloves,” see Guidance for Industry and FDA Staff - Medical Glove Guidance Manual.
- Absorbable powder for lubricating a surgeon’s glove is a class III device, subject to premarket approval application (PMA), see Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove.
- Stratmeyer M Medical Glove Powder Report, September, 1997
- Barbara J, Santais MC, Levy DA, Ruff F, Leynadier Immunoadjuvant properties of glove corn starch powder in latex-induced hypersensitivity Clin Exp Allergy 33, 106-112 2003
- Barbara J, Santais MC, Levy DA, Ruff F, Leynadier F Inhaled cornstarch glove powder increases latex-induced airway hyper-sensitivity in guinea-pigs Clin Exp Allergy 34, 978-983 2004
- Dave J, Wilcox MH. Kellett M Glove powder: implications for infection control J Hospit Infect 42, 283-285 1999
- Dwivedi AJ Kuwajerwala NK, Silva YJ, Tennenberg SD Effects of surgical gloves on postoperative peritoneal adhesions and cytokine expression in a rat model American Journal of Surgery 188, 491-494 2004
- Edelstam G, Arvanius L, Karlsson G Glove powder in the hospital environment - consequences for healthcare workers Int Arch Occup Environ Health75, 267-271 2002
- Edlich RF, Woodward CR, Pine SA, Lin KY Hazards of Powder on Surgical and Examination Gloves: A Collective Review J Long-term Effects of Med Implants 11(1&2) 15-27 2001
- Ellis H Evolution of the surgical glove J Am Coll Surg 207(6) 948-950 2008
- Falk P, Ivarsson ML Examination gloves affect secretion of matrix metalloproteinases and their inhibitors from human abdominal skin fibroblasts Wound Rep Reg 11, 230-234 2003
- Gruenwald J, Eklund A, Katchar K, Moshfegh A, Liden C, Lundgren L, Skare L, Tornling G Lung Accumulation of eosinophil granulocytes after exposure to cornstarch glove powder Eur Respir J 21, 646-651 2003
- Liu W, Nixon RL Corn contact urticaria in a nurse Aust J of Dermatol 48, 130-131 2007
- Malinger G, Ginath S, Zeidel L, Avinoach I, Katz R, Greenberg N, Zakut H, Sadan O Starch peritonitis outbreak after introduction of a new brand of starch powdered latex gloves Acta Obstet Gynecol Scand 79, 610-611 2000
- Nafeh AI, Nosseir M Assessement of peritoneal adhesions due to starch granules of surgical glove powder an experimental study J Egypt Soc Parasitol 37(3) 835-842 2007
- Numanoglu V, Cihan A, Salman B, Ucan BH, Cakmak GK, Cesur A, Balgaloglu H, Ilhanm MN Comparison between powdered gloves, powder-free gloves and hyaluronate/carboxymethylcellulose membrane on adhesion formation in a rat caecal serosal abrasion model Asian J Surg 30(2) 96-101 2006
- Odum BC, O'Keefe JS, Lara W, Rodeheaver RT, Edlich RF Influence of Absorbable Dusting Powder on Wound Infection J Emerg Med 16(6) 875-879 1998
- Reddy VR, Thomas TS, Wright HR, Fisher MD, Edlich RF The Scientific Basis of Surgical Glove Selection in an In Vitro Fertilization Laboratory J Biomed Mat Res (Appl Biomater) 48, 569-571 1998
- Saary MJ, Kanani A, Alghadeer H, Holness DL, Tarlo SM Changes in rates of natural rubber latex sensitivity among dental school students and staff members after changes in latex gloves J Allergy Clin Immunol 109, 131-135 2002
- Sjosten ACE, Ellis H, Edelstam GAB Retrograde migration of glove powder in the human female gemota; tract Human Reproduct. 19(4) 991-995 2004
- Sjosten ACE, Ellis H, Edelstam GAB Post-operative consequences of glove powder used pre-operatively in the vagina in the rabbit model Human Reproduct. 15(7), 1573-1577 2000
- Smithers AR, Winthrop AL, Mesrobian HGO Bilateral scrotal masses in an infant: Remote presentation of an inflammatory reaction to surgical glove powder J Urology 168, 2592-2593 2002
- van den Tol MP, Haverlag R, van Rossen MEE, Bonthuis F, Marquet RL, Jeeke J Glove powder promotes adhesion formation and facilitates tumour cell adhesion and growth Br J Surgery 88, 1258-1263 2001
- Suding P, Nguyen T, Gordon I, Wilson SE Glove Powder Increases Staphylococcus aureus Absecess Rate in a Rat Model Sugical Infections doi:10.1089/sur.2008.055 2009
- Allmers H, Schmengler J, John SM Decreasing incidence of occupational contact urticaria caused by natrual rubber latex allergy in German health care workers J Allergy Clin Immunol 114, 347-351 2004
- Cuming RG Reducing the Hazards of Exposure to Cornstarch Glove Powder AORN J 76, 288-295 2002
- Hermesch CB, Spackman GK, Dodge WW, Salazar A Effect of Powder-free Latex Examination Glove Use on Airborne Powder Levels in a Dental School Clinic J Dental Ed 63(11) 814-820 1999
- Malerich PG, Wilson ML, Mowad CM The Effect of a Transition to Powder-Free Latex Gloves on Workers’ Compensation Claims for Latex-Related Illness Dermatitis 19(6), 316-218 2008
- Vandenplas O, Larbanois A, Vanassche F, Francois S, Jamart J, Vandeweerdt M, Thimpont J Latex-induced Occupational Asthma: Time trend in incidence and relationship with hospital glove policies Allergy 64, 415-420 2009
- Nienhaus A, Kromark K, Raulf-Heimsoth M, van Kampen V, Merget R Outcome of Occupational Latex Allergy – Work Ability and Quality of Life PLoS ONE 3(10): e3459 doi:10.1371/journal.pone.0003459 2008
- LaMontagne AD, Radi S, Elder DS, Abramson MJ, Sim M Primary Prevention of Latex Related Sensitisation and Occupational Asthma: a Systematic Review Occup Environ Med 63, 359-364 2006
- Filon FL , Radman G Latex Allergy: A Follow up Study of 1040 Healthcare Workers Occup Environ Med 63, 121-125 2006
- Uirce S, Swanson MC, Fernandez-Nieto M, de las Heras M, Cuesta J, Sastre J J Allergy Clin Immunol 111(4), 788-794 2003
- Jones KP, Rolf S, Stingl C, Edmunds D, Davies BH Longitudinal Study of Sensitization to Natural Rubber Latex among Dental Students using Powder-free Gloves Ann Occup Hyg 48(5), 455-457 2004
- Allmers H, Schmengler J, Skudlik C Primary Prevention of Natural Rubber Latex Allergy in the German Health Care System Through Education and Intervention J Allergy Clin Immunol 110, 318-323 2002
- Tarlo SM, Easty A, Eubanks K, Parsons CR, Min F, Juvet S, Liss GM Outcomes of a Natural Rubber Latex Control Program in an Ontario Teaching Hospital J Allergy Clin Immunol 108, 628-622 2001
- Liss GM, Tarlo SM Natural Rubber Latex-Related Occupational Asthma: Association with Interventions and Glove Changes Over Time Am J Ind Med 40, 347-353 2001
- Garabrant DH, Schweitzer S Epidemiology of Latex Sensitization and Allergies in Health Care Workers J Allergy Clin Immunol 110, S82-95 2002
- Disposable Medical Gloves - Global Strategic Business Report Global Industry Analysts, Inc., Oct 2008