The FDA, for only the second time ever, wants to ban a medical device. Here’s why.

Shared by Radhika Narayanan | 138 42 2 | about 3 years ago

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.

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