The Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued an order in the Federal Register determining that seven types of surgeon’s gloves and patient examination gloves are reserved class I devices, which require premarket notification (also known as 510(k)).
The product codes within the scope of this order are: LYY, LYZ, OIG, OPC, OPH, LZC, and OPA. This order is now in effect and manufacturers will have 30 additional days to come into compliance.
On January 15, 2021, HHS issued a notice in the Federal Register determining these seven types of surgeon’s gloves and patient examination gloves to be exempt from section 510(k) of the Food, Drug, and Cosmetic Act (FE&C Act).
Then, on April 16, 2021, in the interest of public health, HHS and FDA issued a notice in the Federal Register to explain HHS’s and FDA’s current view on the requirement for premarket notification for these gloves—that is, the class I surgeon’s and patient examination gloves identified will require premarket notification—and to seek public comment. HHS and the FDA received eight comments on that notice, all of which were supportive of the determination that surgeon’s gloves and patient examination gloves meet the reserved criteria and are properly subject to premarket notification.
In issuing the order, HHS and the FDA considered the comments that were submitted to the docket along with our experience in reviewing premarket notifications, focusing on the risks inherent to surgeon's gloves and patient examination gloves and the diseases being prevented, FDA’s experience with these devices, and other relevant considerations.
The FDA Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency does not alter the legal obligation to comply with the relevant legal requirements and does not preclude the FDA from taking action to enforce those requirements where appropriate. The policy, which is limited to the public health emergency and includes risk mitigations, is different from this order.
Establishments seeking to market the Class I reserved devices classified with product codes LYY, LYZ, OIG, OPC, OPH, LZC, and OPA should comply with applicable regulatory requirements, including labeling and requirements for import into the United States.