Effective January 18, 2017, the FDA issued a final rule 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 contact OCEANAIR Compliance at (781) 286-2700 or compliance@oceanair.net.
