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FDA Says Powdered Gloves Have to Go

While use of these gloves is decreasing, agency says they pose an unreasonable and substantial risk of illness or injury.

Published: March 21, 2016

COMPLETE HALT The FDA says the risks associated with powdered gloves can't be corrected through new or updated labeling.

Arguing that they pose an unreasonable and substantial risk of illness or injury, the FDA is finally giving powdered gloves the ultimate thumbs down, proposing a ban on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating surgeons' gloves.

"We take bans very seriously and only take this action when we feel it's necessary to protect the public health," says Jeffrey Shuren, MD, the agency's director of Center for Devices and Radiological Health. The risks associated with the gloves can't be corrected through new or updated labeling, says the FDA, defending its call to completely remove them from the marketplace. The economic impact would be insignificant, it says, because many non-powdered gloves are available.

The action comes 5 years after the FDA posted a request for comments and information based on citizen petitions calling for such a ban.

Powder on latex gloves can carry proteins that may cause allergic reactions, and powdered synthetic gloves are associated with an extensive list of health issues, including severe airway inflammation, wound inflammation, and post-surgical adhesions, says the FDA.

Non-powdered surgeon gloves and non-powdered patient examination gloves aren't included in the proposed ban and will remain Class I medical devices.

You'll be able to comment on the proposed ban at www.regulations.gov for the next 90 days.

Jim Burger


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