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FDA Product Codes on Powdered Medical Gloves to be Deleted

Wednesday, March 22, 2017
Sandler, Travis & Rosenberg Trade Report

According to a U.S. Customs and Border Protection administrative message, the Food and Drug Administration will be deleting the following CDRH (Center for Devices and Radiological Health) product codes effective April 21. Transmission of these codes after this date will result in a reject and will need to be corrected.

- 79KGP (powder, dusting, surgical)

- 79OPG (powdered non-natural rubber latex surgeon’s glove)

- 80OPB (powdered polychloroprene patient examination glove)

- 80OPF (powdered vinyl patient examination glove)

- 80OPD (powdered nitrile patient examination glove)

- 80OPE (powdered latex patient examination glove)

The FDA banned these items as of Jan. 18, 2016, after determining that they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling.

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