The US Food and Drug Administration (FDA) is proposing a ban of most powdered medical gloves in the United States. While use of these gloves is decreasing, the FDA says, “They pose an unreasonable and substantial risk of illness or injury to health care providers, patients, and other individuals exposed to them, which cannot be corrected through new or updated labeling.”
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, 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.”
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 powdered synthetic gloves, can carry proteins that may cause respiratory allergic reactions. 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 postsurgical 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.
As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which—if finalized—would ultimately remove them from the marketplace completely.
The proposed rule is available online at regulations.gov for public comment for 90 days.
