- The FDA, through a proposed rule, seeks to ban most powdered surgical gloves due to potential health risks.
- This is only the second time the agency has moved to pull a medical device from the market, The Washington Post reported. In 1983, the FDA banned prosthetic hair fibers.
- Interested parties have 90 days to comment on the proposed rule.
According to the FDA, the aerosolized powder used on latex gloves can trigger disperse allergens into the air, triggering respiratory reactions. “This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The proposed ban comes 18 years after the consumer advocacy group Public Citizen petitioned the agency to ban the devices — a delay they called “recklessly negligent.” In a statement, Sidney Wolfe, founder and senior advisor of Public Citizens’ Health Research Group, said there was “absolutely no new scientific information today that we didn’t have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves.”
Use of powdered gloves has been on the wan, and the FDA doesn’t expect a ban to cause any hiccup in patient care.
The ban would cover powered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon gloves. It would not apply to powdered radiographic protection gloves.