FDA Proposes Ban on Powdered Gloves

FDA has proposed a ban on powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. An agency notice says that while their use is declining, they still “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 powdered gloves are dangerous because they 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,” the agency says.

FDA’s proposed ban is available at www.regulations.gov for public comment for 90 days.