CSMS# 17-000031 - Publication of a Federal Register Notice Concerning FDA’s Ban on Powdered Gloves
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01/24/2017 06:35 PM EST
Trade Policy Updates
FDA issued a final rule (effective January 18, 2017) banning all powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to health care providers, patients and other individuals. 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 cdrhocimport@fda.hhs.gov 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.
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
FDA issued a final rule (effective January 18, 2017) banning all powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to health care providers, patients and other individuals. 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 cdrhocimport@fda.hhs.gov 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.
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
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