The U.S. Food and Drug Administration on Monday announced a proposed ban against powdered medical gloves that has been five years in the making.
According to the FDA, powder occasionally used by surgeons and nurses to make gloves easier to take on and off can cause serious respiratory allergic reactions. Powdered synthetic gloves, while not associated with allergies, are linked to a variety of potentially serious medical complications, including wound inflammation and post-surgical adhesions, or bands of scar tissue that form between internal organs and tissues.
The ban, if approved, would apply to powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove, the FDA said.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Dr. Jeffrey Shuren of the 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.”
The announcement comes five years after the FDA first asked the public for thoughts on a ban after the agency received a pair of petitions arguing that the use of powdered gloves carried an unnecessary health risk.
By the time the FDA closed comments on the subject in April 2011, the agency had received 285 comments.
Before proposing the ban, officials reviewed scientific literature on the use of powdered medical gloves and studied the possible impact of such a ban on the medical profession.
The FDA determined that the wide availability of similar, non-powdered gloves meant a ban would have little, if any, impact on medical practitioners.
The FDA will take comments on the proposed rule for 90 days.
Cox Media Group
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