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FDA Proposes Ban on Most Powdered Medical Gloves
The FDA has announced a proposal to ban most powdered gloves in the United States. While the 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, which cannot be corrected through new or updated labeling, the agency said.
The proposed ban applies to powdered surgeons’ gloves, powdered patient-examination gloves, and absorbable powder for lubricating surgeons’ gloves.
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, the FDA says. 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. 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 (bands of fibrous scar tissue that form between internal organs and tissues). These adverse effects have been attributed to the use of glove powder with all types of gloves.
Because these risks cannot be corrected through new or updated labeling, the FDA is moving forward with its proposal to ban these products, which––if finalized––would ultimately remove them from the marketplace completely.
The FDA has determined that the banning standard would not apply to powdered radiographic protection gloves. The agency is not aware of any powdered radiographic protection gloves that are currently on the market. Nonpowdered surgeons’ gloves and nonpowdered patient examination gloves will also not be included in the ban and will remain class I medical devices.
Source: FDA; March 21, 2016.