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Citizen Petitions Prompt FDA Guidance on Glove Labeling

February 24, 2011
The FDA is recommending labeling changes for powdered medical gloves after two citizen petitions warned of potential adverse health effects. The petitions requested the agency ban powder on surgeon and patient examination gloves because of allergic and foreign body reactions, formation of granulomas and peritoneal adhesion, especially with multiple surgeries. The glove powder can also serve as a carrier of endotoxins, the agency says. The draft guidance suggests a warning for the new labels, informing users of the potential adverse health effects. Comments are due by May 9.
Devices & Diagnostics Letter