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Medical Device Safety Alert: FDA Bans Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove


The United States Food and Drug Administration (FDA) has issued a medical device ban concerning Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove.

The FDA has determined that powdered medical gloves present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

According to the FDA, a thorough review of all currently available information supports FDA's conclusion that the risks posed by powdered gloves, including health care worker and patient sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, are important, material, and significant in relation to the benefit to public health from their continued marketing.

Please refer to the following website for details:
https://www.federalregister.gov/documents/2016/12/19/2016-30382/
banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder

Posted on 19 December 2016

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Last Revision Date : 19 December 2016