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FDA Proposes Ban on Powdered Gloves

Defective Devices / April 8, 2016

Safe examination gloves are a medical necessity.

Standardization in gloves is a necessity in keeping patients safe from other patients and medical staff and patients safe from each other. Per the FDA, “Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.” Gloves keep not only patients safe, they protect the nurses, doctors, and surgeons we rely on to give us quality care. What happens though when gloves could be a contributing factor to a patient or provider’s illness?

Powdered gloves have been used by healthcare professions since at least the late 19th century. At first, the gloves were covered in Lycopodium spores or ground pine pollen. By the 1930s, lycopodium spores and ground pine pollen were replaced by talc powder as Lycopodium powder was likely to cause wound granulomas and adhesion formation. Talcum powder didn’t last long as a substitute though, by the 1940s talc was also shown to contribute to postoperative adhesions and granuloma formulation. Modified cornstarch powder was presented as an absorbable and non-irritating glove powder in 1947 and by the 1970s it surpassed talc usage. Powdered gloves with modified cornstarch seemed to be a perfect solution until 1997, the FDA “found that glove powder could cause inflammation and granulomas” and “aerosolized glove powder on natural rubber latex gloves can carry allergenic proteins that have the potential to cause respiratory allergic reactions.” Not only do powdered gloves pose an allergen threat, the inflammation that they cause can lead to cancer – such as the talc inflammation has been tied to ovarian cancer.

Powdered gloves provide a false sense of security.

In 1998 Public Citizen, a nonprofit organization lobbying for citizen interests in Washington, D.C., called on the FDA to ban cornstarch in latex surgical and patient examination gloves. The FDA, finding that a ban on powdered gloves would create a shortage of regulation gloves while driving increased costs to the healthcare system, instead began recommending “that medical gloves have no more than 2 mg of residual powder or debris per glove.” This was a stark decrease from the 120-400 mg of residual particulates, mold release, and donning powder gloves generally contained. After receiving three more petitions to ban cornstarch powdered gloves, the FDA has finally decided to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove on the basis that the gloves, as a medical device, “present substantial deception or an unreasonable and substantial risk of illness or injury.” Gloves give healthcare professionals and patients a sense of security, the powder on these gloves are a deception to that sense of security in that they can cause more damage than many of the illnesses they seek to prevent.
Rather than banning products, the FDA often proposes changing the marketing on problematic medical devices. However, powdered gloves present enough of a substantial deception and unreasonable and substantial risk of illness or injury that a change of marketing would not suffice. The ban would benefit both healthcare professionals and patients from unnecessary complications and ailments. This ban will save lives and promote better quality of life for everyone involved. The FDA is currently seeking input from the public on this proposed ban, comments are accepted until June 20th, 2016.

The FDA has proposed a ban on powdered gloves, but remain silent on the dangers of talcum powder.