WASHINGTON—Powdered surgical gloves, powdered patient examination gloves and absorbable powder for surgical gloves would become illegal in the U.S. if a proposed rule from the U.S. Food and Drug Administration becomes final.
“While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them,” the FDA said in a news release accompanying publication of the document in the March 22 Federal Register.
Glove makers use powders to make gloves easier to put on or take off, the FDA said. However, aerosolized powder on natural rubber latex gloves can carry programs that may cause allergic respiratory reactions, it said.
Allergic reactions don't occur when the gloves are synthetic rubber latex, according to the FDA. However, powder on SR gloves is associated with severe airway inflammation, wound inflammation and post-surgical adhesions, the agency said.
The FDA said it considered all available evidence in crafting the proposal, including a February 2011 Federal Register notice calling for comments on the risks and benefits of powdered gloves. A total of 285 comments were received in response to that notice, according to the website Regulations.gov.
Interested parties have until June 20 to submit written or electronic comments. The March 22 proposal can be found by clicking here.