After reviewing available information, the FDA announced a proposal on March 21 to ban most powdered gloves, including powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon’s gloves.
The ban would not apply to powdered radiographic protection gloves or non-powdered surgeon gloves and non-powdered patient examination gloves.
The FDA noted in a news release that powdered gloves are associated with risks of illness and injury to healthcare providers and patients.
For instance, aerosolized glove powder on natural rubber latex gloves can carry protein that may cause respiratory allergic reactions, according to the FDA. Further, powdered synthetic gloves are associated with severe airway inflammation, wound inflammation and post-surgical adhesions.
The FDA said labeling updates or changes would not alleviate the risks. Thus, it is proposing to remove all of these products from the market.
Before making the decision, the FDA reviewed scientific literature and comments received on a February 2011 Federal Register Notice and conducted an economic analysis, which showed the ban would not cause a glove shortage and would not have a significant economic impact. The FDA also said many non-powdered protective gloves are available.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, said in a news release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”