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In Rare Move, FDA Bans Powdered Gloves

Agency says powdered gloves present an unreasonable health risk to medical professionals and their patients.

Published: December 16, 2016

BANNED FDA believes the ban will have minimal economic as healthcare providers transition to non-powdered alternatives.

Powdered surgeon's gloves, powdered patient examination gloves and the absorbable powder used to lubricate a surgeon's glove present "an unreasonable and substantial health risk" to healthcare providers and their patients. So says the FDA, which on Monday will publish its final rule to effectively ban all powdered medical gloves with the exception of powdered radiographic protection gloves. The FDA has not taken such action on a medical device in 33 years.

Adverse events attributed to the use of powdered gloves include severe airway inflammation, hypersensitivity reactions and allergic reactions, including asthma, as well as damage or postsurgical bands of fibrous scar tissue that form between internal organs and tissues. In its final rule on the matter, FDA concluded that the risks posed by the continued marketing of these gloves exceed the benefit.

The ban will be effective on Jan. 19, 2017. FDA said it believes the ban will have minimal economic and shortage impact as the healthcare industry transitions to non-powdered alternatives, which provide similar protection, dexterity, and performance as powdered gloves. FDA suggested banning powdered gloves would reduce the number of associated adverse events, as well as the resulting costs, which it estimated at $26.8 million to $31.8 million annually.

Although the ban has received strong support, it also received pushback from powdered-glove proponents, including medical professionals. During a comment period that followed FDA's announcement of the proposed rule on March 22, 2016, FDA received a number of letters in which some commenters noted powdered gloves' superior tactile sense, while others suggested some of the powdered gloves currently on the market pose a reduced risk because they have less powder.

Medical-device bans are exceedingly rare. FDA has banned only one other medical device, prosthetic hair fibers, in June 1983. A proposed ban on electrical stimulation devices used for self-injurious or aggressive behavior was issued on April 22, 2016.

Bill Donahue


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