FDA Proposes Ban on Powdered Gloves Used in Health Care Because of Adverse ReactionsMar 28, 2016
The U.S. Food and Drug Administration (FDA) announced a proposed a ban on most powdered protective gloves used by health care providers in the United States.
The use of powdered gloves is decreasing, but the FDA said the gloves pose substantial risks to health care providers, patients, and other individuals who are exposed to them. Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said the ban "is about protecting patients and health care professionals from a danger they might not even be aware of."
The ban-if finalized-would apply to powdered surgeon's gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeons' gloves. The risk cannot be corrected through labeling changes, the agency says.
The FDA explains that powder is sometimes added to gloves to make it easier to put them on and take them off, but powdered gloves are dangerous for a variety of reasons. Aerosolized glove powder on natural rubber latex gloves (but not on synthetic powdered gloves) can carry proteins that may cause respiratory allergic reactions. The powdered gloves are associated with 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.
Because the risks cannot be corrected through label changes, the FDA is moving forward with the proposal to ban powdered gloves and they would ultimately be removed from the marketplace.
The FDA says that in making the decision to propose a ban, it considered all available evidence, and conducted a thorough review of the scientific literature and comments received after a February 2011 notice about gloves in the Federal Register. The agency also conducted an economic analysis that showed the 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 gloves are currently available.
The ban would not apply to powdered radiographic protection gloves, though the agency is not aware of any powdered radiographic protection gloves currently on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices, which present minimal risk of harm to the user and are the most lightly regulated.
The text of the proposed rule can be found online at www.regulations.gov. The FDA says public comment on the rule will be open for 90 days.