The FDA has proposed a ban on most powdered medical gloves in the United States due to concerns they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are exposed to them. These risks “cannot be corrected through new or updated labeling,” the FDA said in a news release.
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
According to the agency, powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. “In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions,” the agency noted.
“Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are 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. These side effects have been attributed to the use of glove powder with all types of gloves.”
The proposed rule is available online at www.regulations.gov for public comment for 90 days.