The US Food and Drug Administration (FDA) announced a proposal to ban most powdered gloves in the United States. 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 proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of 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.”
Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. 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.
As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which – if finalized – would ultimately remove them from the marketplace completely.
In making the determination that these products are dangerous and present an unreasonable and substantial risk, the FDA considered all available evidence, which included a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice. 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. 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. Therefore, the FDA is also proposing amendments to their classification regulations to clarify that they apply only to non-powdered gloves.
The proposed rule is available online at www.regulations.gov for public comment for 90 days.