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FDA Moves to Ban Powdered Gloves in Healthcare
March 21st, 2016
By Gary Evans, Senior Staff Writer
The Food and Drug Administration announced a proposal to ban powdered gloves today, citing the ongoing "dangerous" risk of allergic reactions to healthcare workers and patients.
While use of these gloves is decreasing, the FDA decided 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 ban -- which will be open for comment for 90 days -- applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgical gloves. Non-powdered surgeon gloves and non-powdered patient examination gloves will not be included in the ban and will remain Class I medical devices.
“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 statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
Powder is typically added to gloves to ease donning and removal, but can spread latex allergens if aerosolized and inhaled. Reported allergic reactions have included severe respiratory problems in healthcare workers and others with latex allergies. Although powdered synthetic gloves do not present the risk of latex allergic reactions, these gloves "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 noted.
Deciding the risk cannot be mitigated through new or updated labeling, the FDA is moving forward with the proposal to ban powdered gloves. The agency cited information gathered in a 2011 review of the literature and request for comment on the issue in determining the gloves "are dangerous and present an unreasonable and substantial risk."
In addition, given the critical role medical gloves play in protecting patients and health care providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant. The ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available. The FDA has determined that the banning standard would not apply to powdered radiographic protection gloves. The agency is not aware of any powdered radiographic protection gloves that are currently on the market.