The Food and Drug Administration proposed a ban on most powdered medical gloves on Monday, saying that they “pose an unreasonable and substantial risk” to healthcare workers and patients.
The proposed ban would apply to powdered surgeon’s gloves, powdered patient examination gloves and an absorbable powder used for lubricating surgeon’s gloves. Use of the gloves has been decreasing, but they still carry a risk that can’t be corrected through new or updated labeling, the FDA noted.
Powdered synthetic medical gloves, as well as the aerosolized powder used on natural rubber latex gloves, can cause severe airway inflammation, wound inflammation and post-surgical adhesions, or fibrous scar tissue that forms between internal organs and tissues. The powder used on natural gloves can also pose a risk of respiratory allergic reactions.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., 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.”
If finalized, the ban would remove most powdered gloves from the market entirely. It’s unlikely that the ban would negatively impact medical practices or facilities, since non-powdered glove options are widely available, FDA said.
