FDA proposes powdered glove ban

The FDA has announced a proposal to ban most powdered gloves in the United States, which would effectively remove them from the marketplace, according to a press release issued by the agency.

While the FDA acknowledged that use of the gloves is decreasing, the agency stated that they "pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them" and that risk cannot be fixed with labeling.

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

The FDA has proposed the ban of powdered patient examination gloves, powdered surgeon gloves, and the absorbable powder for lubricating surgeon gloves. The ban does not apply to nonpowdered surgeon gloves or patient examination gloves.

After a review of evidence, the FDA determined that the powder is "dangerous" and presents "an unreasonable and unsubstantial risk." The agency also found that a ban would not significantly impact medical practice or cause a glove shortage.

The powder can cause respiratory allergic reactions, post-surgical adhesions severe airway inflammation, and wound inflammation, according to the FDA.

The ban is open to public comment for 90 days.