FDA proposes a ban on powdered medical gloves
The FDA has announced a proposal to ban most powdered gloves in the United States.
The FDA has proposed a ban on use of most powdered medical gloves. The ban would apply to powdered surgeons' gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeons' gloves.
According to the FDA, these gloves “pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients, and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.”
Aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, may carry proteins that can cause respiratory allergic reactions. Powdered gloves have been associated with a number of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions.
“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 the 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 FDA considered all available evidence on the issue, including a thorough review of the scientific literature and comments received regarding a February 2011 Federal Register Notice. Furthermore, the FDA conducted an economic analysis, which concluded that 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 affect medical practice, as many nonpowdered protective glove options are available.
The proposed ban does not apply to powdered radiographic protection gloves. 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.
The proposed rule is available online at www.regulations.gov for public comment for 90 days.
- FDA proposes ban on most powdered medical gloves. Silver Spring, MD: U.S. Food and Drug Administration. Published March 21, 2016. Updated March 30, 2016. Accessed April 11, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466