On March 21, 2016, the U.S. Food and Drug Administration (FDA) proposed a ban on most powdered gloves used in health care in the United States. The use of these gloves is decreasing, but they pose a substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, and the risk 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.
Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said the ban “is about protecting patients and health care professionals from a danger they might not even be aware of.”
Powder is sometimes added to gloves to help make it easier to put them on and take them off, but powdered gloves are dangerous for a number of reasons. Aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. The powdered gloves 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.
Because the risks cannot be corrected through label changes, the FDA is moving forward with the proposal to ban these products, which would ultimately remove them from the marketplace completely.
In making the decision to propose a ban, the FDA considered all available evidence, and did a thorough review of the available scientific literature and comments received after a February 2011 notice in the Federal Register. The FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant. The ban is also not likely to impact medical practice, the agency says, because many non-powdered protective gloves are currently available.
The ban would not apply to powdered radiographic protection gloves, though the agency is not aware of any powdered radiographic protection gloves currently on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices. The FDA is proposing amendments to their classification regulations to clarify that they apply only to non-powdered gloves.
Interested parties can see the proposed rule online at www.regulations.gov. Public comment will be open for 90 days.