FDA Issues Ban on All Medical Grade Powdered Disposable Gloves Effective January 18, 2017

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The FDA has issued a ban on all medical grade powdered disposable gloves effective January 18, 2017. This final rule, issued December 19, 2016, reads in part:

“The Food and Drug Administration has issued a final rule that, effective Jan. 18, will ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove after having determined that these goods present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. This ban will apply to such goods already in commercial distribution or sold to the ultimate user as well as those that would be sold or distributed in the future. The ban does not apply to the non-powdered versions of the above types of gloves, powder used in the manufacturing process of non-powdered gloves where that powder is not intended to be part of the final finished gloves, or powder intended for use in or on other medical devices.”

The full text from the Federal Register can be found at:
https://www.regulations.gov/document?D=FDA-2015-N-5017-0173

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