The U.S. FDA has announced a proposal to ban most powdered gloves in the United States.
The use of powdered gloves, once the staple in ORs around the world, has been decreasing for years now. The benefits of being able to more easily don powdered gloves have been outweighed by the problems caused by the powder, most famously post-surgical adhesions, but also respiratory allergic reactions (powdered natural latex gloves).
The FDA’s view is that the powder poses an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to it, which cannot be corrected through new or updated labeling.
The proposed ban, which is open for feedback for 90 days, applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
More information can be found here.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”