Content Dam Diq Online Articles 2016 03 Medical Gloves Thumb
Content Dam Diq Online Articles 2016 03 Medical Gloves Thumb
Content Dam Diq Online Articles 2016 03 Medical Gloves Thumb
Content Dam Diq Online Articles 2016 03 Medical Gloves Thumb
Content Dam Diq Online Articles 2016 03 Medical Gloves Thumb

FDA proposes ban on most powdered medical gloves

March 22, 2016
The FDA has determined that powdered gloves 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 FDA has determined that powdered gloves 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.

On March 21, 2016, the US Food and Drug Administration 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 surgical gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves.

“This ban is about protecting patients and health-care 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.”

READ MORE | Take your gloves seriously

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 nonpowdered protective glove options are currently available.

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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. Nonpowdered surgeon gloves and nonpowdered 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 nonpowdered gloves.

The proposed rule is available online at www.regulations.gov for public comment for 90 days.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.—FDA press release 21 March 2016

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