The FDA is concerned about potential adverse health effects when powdered medical gloves are used, such as foreign body reaction, formation of granulomas and peritoneal adhesion, especially with multiple surgeries.
The FDA is suggesting the following warning statement for medical gloves that use powder:
“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 is recommending manufacturers of powdered gloves include this warning on their product labels no later than six months after issuance of final guidance based on this draft, and sooner if possible.
Comments and suggestions regarding the draft guidance should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Read the FDA’s report on the draft guidance for powdered medical gloves.
Read the AORN report about the FDA draft guidance.
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