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FDA proposes to ban powdered surgeon's & examination gloves

Discussion in 'US Medical Device Regulations' started by Ronen E, Mar 22, 2016.

  1. Ronen E

    Ronen E Well-Known Member

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    "Today the FDA published a Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove.

    While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, the powder used on some gloves has been proven to cause serious injury. Risks include respiratory allergic reactions, lung inflammation, post-surgical adhesions and possibly death. The FDA has determined that use of these gloves and glove powder is dangerous and presents unreasonable and substantial risk that cannot be corrected through new or updated labeling."
     

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