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SEMPERGRAMS


April 27, 2011
FDA Issues Draft Guidance Regarding Powdered Gloves
There continues to be much confusion surrounding a recent draft guidance document recently published by FDA entitled “Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder.” This draft guidance was issued in response to continued concerns related to adverse health effects that could result from the use of medical gloves that contain powder. As a result, FDA recommends that labeling for powdered medical gloves include a warning statement which indicates the potential risks associated with powder. The FDA issued this draft guidance on 7 February 2011. A 90-day public comment period extended until 25 April 2011. The Agency is now reviewing information prior to finalizing the guidance document.

The recommended warning statement is as follows (it may be modified prior to any FDA approval): 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.

Despite the recommendation, this warning statement is not currently required on powdered glove packaging, nor will it be required if a final guidance is issued. FDA's guidance documents describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. Nonetheless, glove suppliers should give serious consideration to its inclusion on powdered glove labeling.

More information on this draft guidance is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm228557.htm

If you need additional information or assistance on technical issues concerning Sempermed gloves, please contact our Customer Service representatives at 800-366-9545.