04/12/2016

FDA calls for powdered exam gloves ban


The U.S. Food and Drug Administration (FDA) is proposing to ban the use of most powdered gloves, including powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.

Powder is added to gloves to help make it easier to put them on and remove them, but these type of gloves, according to the FDA "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 FDA says 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 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 FDA said in a statement.

Public comments are being accepted on the proposed rule online at regulations.gov.



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