The Food and Drug Administration (FDA) has proposed a ban on most powdered gloves in the United States. Powdered gloves carry a substantial risk of illness or injury to healthcare providers, patients, and others who are exposed to them that cannot be corrected through new or updated labeling.

The proposal applies to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. The ban would not apply towards powdered radiographic protection gloves, non-powdered surgeon gloves, or non-powdered patient examination gloves.

Powder is added to gloves to make them easier to put on and take off but it can be dangerous for several reasons. Aerosolized glove powder on natural rubber latex gloves but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions.


Continue Reading

Powdered synthetic gloves may not pose the risk of allergic reactions but they are linked to many potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions.

The FDA reviewed all current data and evidence, including comments received on a Federal Register Notice from February 2011. The Agency also performed an economic analysis that demonstrated a ban on powdered gloves would not cause a glove shortage nor would it have a significant economic impact. The ban would also not likely impact medical practice because many non-powdered protective glove options exist.

The FDA is proposing a ban on these products as these health risks cannot be corrected through new or updated labeling. If the ban is finalized, powdered gloves would be removed from the market completely. In addition, the FDA is proposing amendments to classification regulations to clarify that they apply to non-powdered gloves.

Summary and Clinical Applicability

“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 the Center for Devices and Radiological Health at the FDA, in an agency news release.  The proposed rule is available online and open for public comment for 90 days.

Reference

U.S. Food and Drug Administration News Release. FDA proposes ban on most powdered medical gloves. Published online March 21, 2016, Access March 21, 2016. Source Code. 

The proposal is available online for public comment for 90 days.

For more information call (888) 463-6332 or visit FDA.gov.

This article originally appeared on MPR