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Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder

PDF Printer VersionDocument issued on: February 7, 2011

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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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For questions regarding this draft guidance document contact Subhas Malghan (OSEL) at 301-796-2548, or by e-mail at Subhas.malghan@fda.hhs.gov; or Sheila Murphey (ODE) at 301-796-6302, or by e-mail at sheila.murphey@fda.hhs.gov.

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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Office of Science and Engineering Laboratories

Infection Control Devices Branch
Division of Anesthesiology, Gen Hospital, Infection Control, & Dental Devices
Office of Device Evaluation

 

Preface

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov 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

  1. Introduction
  2. Scope
  3. Background
  4. Recommended Warning Statement
  5. References

Draft Guidance for Industry, Clinical Laboratories and FDA Staff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This draft guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.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.

1. Introduction

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.

2. Scope

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.

3. Background

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.

4. Recommended Warning Statement

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.

5. References

  1. For more information on “medical gloves,” see Guidance for Industry and FDA Staff - Medical Glove Guidance Manual.
  2. 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.
  3. Stratmeyer M Medical Glove Powder Report, September, 1997
  4. 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
  5. 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
  6. Dave J, Wilcox MH. Kellett M Glove powder: implications for infection control J Hospit Infect 42, 283-285 1999
  7. 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
  8. Edelstam G, Arvanius L, Karlsson G Glove powder in the hospital environment - consequences for healthcare workers Int Arch Occup Environ Health75, 267-271 2002
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  11. 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
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  13. Liu W, Nixon RL Corn contact urticaria in a nurse Aust J of Dermatol 48, 130-131 2007
  14. 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
  15. 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
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  17. 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
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  37. 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
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