The U.S. Food and Drug Administration (FDA) on Monday announced a proposal to ban powdered medical gloves in the United States.
"While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to doctors, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling," the FDA said in a statement.
The proposed ban, now open for public comment for 90 days, applies to powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.
The rule does not include powdered radiographic protection gloves. The agency said it's not aware of any such devices that are currently on the market.
According to the FDA, powder is sometimes added to gloves to help make it easier to put them on and take them off.
However, powdered gloves are very dangerous. For example, aerosolized glove powder on natural rubber latex gloves can carry proteins that may cause respiratory allergic reactions.
Glove powder, not only on natural rubber latex gloves, but with all types of gloves, is also associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in the statement.
An FDA economic analysis showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant.
In addition, the ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available, the agency said.
