FDA Proposes Ban on Powdered Gloves

The FDA is proposing a ban on powdered gloves in most medical situations.

Use of powdered gloves is on the decline, but some medical professionals and patients may remain at risk for aerosolized glove powder, which can cause respiratory allergic reactions.

In addition, powdered synthetic gloves are associated with adverse events such as severe airway inflammation, wound inflammation, and post-surgical adhesions.

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

The proposed ban affects powdered surgeon gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove.

Risks associated with powdered gloves cannot be corrected through new or updated product labeling, according to the FDA, which is why the agency has proposed a complete ban. If the proposed ban is finalized, these products would be removed from the marketplace.

The FDA stated it had conducted an economic analysis that found a ban would not lead to a glove shortage, and the economic impact would not be significant. The FDA noted that many non-powdered glove options are available.

This proposed ban would not apply to powdered radiographic protection gloves, though none exist on the market right now.

Those who wish to comment on this proposed rule can do so at www.regulations.gov.