The effective date of this rule applies to devices already in commercial distribution and those already sold to the ultimate user, as well as to devices that would be sold or distributed in the future. Section 501(g) of the FD&C Act (21 U.S.C. 351(g)) deems a device to be adulterated if it is a banned device. Importers, manufacturers, and customs brokers should take note that powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove offered for import into the United States will be subject to refusal of admission.
For more information please visit the FDA Medical Device Bans webpage. Questions regarding FDA’s ban of powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove should be directed to FDA’s Center for Device and Radiological Health CDRH OC Import mailbox at email@example.com or 240-402-4020. Questions regarding FDA’s import processes can be directed to FDA’s Division of Import Operations at FDAImportsInquiry@fda.hhs.gov.
To download an Adobe copy of this FDA FRN please follow this link: FRN on Powdered Gloves