FDA proposes ban on powdered gloves, invites public comment
March 22, 2016
The U.S. Food and Drug Administration March 21 announced
a proposal to ban most powdered gloves in the U.S.
"While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling," the agency said in a news release.
The ban would apply to powdered surgeon's gloves, powdered patient exam gloves and absorbable powder for lubricating a surgeon's glove.
The powder that is sometimes added to natural rubber latex gloves to make them easier to take on and off can carry proteins that may cause respiratory allergic reactions, the FDA said, adding that "although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves," the FDA said.
The proposed rule is available online at www.regulations.gov
for public comment for 90 days.
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