The U.S. Food and Drug Administration (FDA) has announced a proposal to ban most powdered gloves in the U.S., as they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are exposed to them—a risk that cannot be corrected through new or updated labeling, according to the FDA.
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. 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 postsurgical adhesions. These side effects have been attributed to the use of glove powder with all types of gloves. If the ban is finalized, these products would ultimately be removed from the marketplace completely.
The FDA determined the risk based on all available evidence, including a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice. In addition, it 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 practices, because many non-powdered protective glove options are currently available.
The banning standard would not apply to powdered radiographic protection gloves, as 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.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, 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.”
The proposed rule is available at www.regulations.gov.
