Citing dangerous allergens and inflammation, the U.S. Food and Drug Administration has proposed a ban on powdered medical gloves. The agency says that the powder can get into wounds and cause scars or inflammation in the body after surgery. The F.D.A. also says that the powder can carry dangerous allergens into the air. The New York Times reports:
The powder is added to the gloves by manufacturers to make it easier to put them on and take them off. But experts have known for some time that the powder can cause harm. The agency did not specify the precise percentage of gloves that now have powder, but a spokesman for the agency, Eric Pahon, said it was very small. The proposal is open for public comment for 90 days.
The agency started to warn about the gloves in 1997, but refrained from banning them then, largely because it determined that pulling them from the market at the time could cause shortages and would be disruptive to the practice of medicine. The ban would apply to powdered surgeon’s gloves, powdered patient-examination gloves and absorbable powder for lubricating a surgeon’s glove.
The Washington Post writes:
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.
"While 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 FDA said in a statement.
"The proposed ban applies to powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove."
