Powdered medical gloves, including surgeon's and patient examination gloves, should carry a warning label about the potential adverse health effects associated with powder, the U.S. Food and Drug Administration said Monday.

In a draft guidance document to manufacturers, the FDA expressed concern that users and patients may not be aware of the potential negative consequences related to powdered gloves, including allergic reactions and respiratory problems.

Although guidance documents from the FDA are not binding, manufacturers traditionally tend to adopt the agency's recommendations.

In its reasoning for proposing the recommendation, the agency cited findings from its 1997 report that investigated the allergic reactions associated with gloves made of natural rubber latex, vinyl and polychloroprene. The cornstarch often found in glove particles "affects wound healing, inflammation, adhesion formation, granulomatous peritonitis, respiratory function, as well as allergic responses," the FDA found.

The agency is now seeking comments and suggestions on the proposal, which will be accepted through April.

If formally adopted, the FDA recommends powdered gloves to carry the following 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."

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