FDA Draft Guidance Calls For Warnings About Powdered Surgeon Gloves
Federal regulators are recommending that new warnings be added to all powdered surgeon’s gloves and patient examination gloves to help avoid allergic reactions, respiratory problems and other potential side effects.
The powdered glove draft guidance was issued by the FDA on February 2. It calls for all powdered gloves used by health care professionals to carry warnings regarding their health risks.
An FDA guidance represents the agency’s recommendations to industry and the medical community, and is not a binding rule.
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The recommended warning would apply to all powdered gloves used in a health care setting, but are specifically targeted at surgeon’s gloves and patient examination gloves that are covered in powdered latex, synthetic non-latex, polychloroprene, nitrile and vinyl. The recommended warning would read:
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.
The FDA first issued a Medical Glove Powder Report in 1997, warning that the agency had received adverse health event reports regarding the use of the gloves that included respiratory allergic reactions, rhinitis, conjunctivitis, dyspnea, respiratory problems, granuloma formation and peritoneal adhesions. Since that time, other medical studies have raised concerns over powdered medical glove side effects, but the FDA notes that the findings have not been universal.
The FDA has opened up a 90-day comment period on this draft guidance before it decides whether, and in what form, it will make the guidance final. However, the FDA is urging powdered medical glove manufacturers to begin utilizing the warning, or a substantially similar warning of their own wording, as soon as possible.
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