Powdered medical gloves — the kind used in surgery or to examine patients — would be ordered off the market under a new proposal by the Food and Drug Administration. That would put the gloves in an exclusive club — only one other device has been banned by the agency: prosthetic hair fibers in 1983.
When an already approved device turns out to pose higher-than-expected risks, the agency usually tries to correct the problem by adding a warning to the label or changing how the device is used. But in the case of the gloves — and the hair fibers — the FDA concluded that no labeling fixes would do the trick. The hair fibers, intended for implantation into the scalp, did not stimulate hair growth or conceal baldness and could cause infections, the agency concluded at the time.
The use of powdered medical gloves has been declining in recent years, and the agency doesn't expect any disruption in clinical care if they are banned. The powder is designed to make it easier to pull the gloves on and off, but it also poses "an unreasonable and substantial risk of illness or injury to health-care providers, patients and other individuals who are exposed to them," the agency said.
The FDA said the aerosolized powder on latex gloves can spark respiratory allergic reactions. Powdered synthetic gloves don't pose that risk, but may result in airway and wound inflammation and post-surgical adhesions — fibrous scar tissue, the agency said.
"This ban is about protecting patients and health-care 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 consumer advocacy group Public Citizen, which petitioned the FDA in 1998 to ban powdered surgical latex gloves, on Monday chastised the agency for waiting so long to take such an action.
"The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is," Sidney Wolfe, a founder and senior advisor tot he group, said in a statement. "There is 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."
The FDA issued a warning about powdered gloves used in surgery and patient examination in 2011. As far back as 1997, the agency put out a "Medical Glove Powder Report" that discussed the potential health risks of the powder.
The agency will accept public comment on the proposed ban for 90 days.
This post as been updated.
Brady Dennis contributed to this report.