FDA proposes ban on powdered medical gloves

The FDA today unveiled a proposal to ban most powdered medical gloves in the U.S.

The agency said that while the use of such gloves is decreasing, they still pose an unreasonable and substantial risk of illness or injury to both providers and patients, as well as other individuals who are exposed to them.

The agency’s proposed ban applies to surgeons gloves, examination gloves and absorbable powder designed for lubricating surgeons gloves, according to a press release.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of. We take bans very seriously and only take this action when we feel it’s necessary to protect the public health,” FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren said in a press release.

Powder is added to gloves to make it easier to put them on and take them off, but the FDA said the powder can be dangerous for a variety of reasons.

Included in the list was the chance that the aerosolized glove powder may carry proteins that may cause respiratory allergic reactions, produce severe airway inflammation, wound inflammation and post-surgical adhesions. All of these effects have been attributed to the use of glove powder with a variety of different gloves.

The risks mentioned cannot be corrected through new or updated labeling, the FDA said, and therefor it is seeking to ban the products outright.

The federal agency said it considered “all available evidence” in making the decision, including a review of scientific literature and comments it received in a February 2011 federal register notice.

The FDA said the ban would not apply to powered radiographic gloves, and non-powered surgeon gloves and patient examination gloves woudl also not be included, but would remain Class I medical devices.

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