The Blog


FDA Bans Powdered Medical Gloves

John Calhoun

On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final ruling banning powdered surgical gloves and powdered examination
gloves, as well as the absorbable powder used in the manufacture of powdered surgical gloves. Published in the Federal Register (Vol. 81, No. 243), this ruling is summarized as follows:

“This rule is effective January 18, 2017. The effective date applies to gloves
already in commercial distribution and those already sold to the ultimate users, as well as to devices that would be sold or distributed in the future. All powdered surgeon’s gloves, powdered patient examination gloves, and
absorbable powder for lubricating a surgeon’s gloves must be removed from the market upon the effective date of this final rule.”

Any powdered medical gloves remaining on the market after January 18, 2017, including any currently in use by end-users, would be deemed by the FDA to be adulterated and unusable. The gloves are not defective; the FDA considers any banned devices to be adulterated regardless of their condition. This ban does not include powdered radiographic protection gloves, nor does it apply to powder used in the manufacturing process (e.g. as a former-release agent) of powder-free gloves, where the powder is not intended to be part of the final finished glove.

The FDA has not ordered that powdered gloves be recalled. Rather, they are
relying on each segment of the supply chain, including end users, to remove powdered gloves from the market. The FDA recommends that unused powdered medical gloves at distribution locations, hospitals, outpatient centers, clinics, medical and dental offices, nursing homes, etc. be disposed of according to established industry practices and procedures. Manufacturers may export existing inventory of powdered gloves to a foreign country if applicable.

The final rule may be viewed and downloaded at:
https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf

The initial proposal for this ruling was published by FDA on March 22, 2016
(Federal Register Vol. 81, No. 55). A public comment period extended to June 20, 2016, during which the FDA received approximately 100 comment letters. Information on the proposed ban was discussed in a previous SemperGram Technical Bulletin, issued May 3, 2016.


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