Medical Devices; Class I Surgeon's and Patient Examination Gloves

Issuing agencies

Abstract

The Department of Health and Human Services (HHS or "the Department") issued a Notice in the Federal Register of January 15, 2021, ("the January 15 notice") which identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or "the Agency") issued a Notice in the Federal Register of April 16, 2021 ("the April 16 notice") explaining the basis for our current view that the seven types of reserved class I devices identified in the January 15 notice require a premarket notification, and explaining why the reasoning supporting the prior determination was unsound. HHS and FDA sought comment on the matters discussed in the April 16 notice, and have considered the comments that were submitted to the docket. HHS and FDA are issuing this final order and determination that the seven types of class I surgeon's gloves and patient examination gloves listed in the January 15 notice are reserved class I devices for which a premarket notification is required.