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# Gloves Remain Class 1; 510(k) Required
- URL: https://www.fdaweb.com/gloves-remain-class-1-510-k-required/
- Published: 2021-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:07:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149780

*Federal Register* notice: FDA has rescinded a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determined no longer require premarket notification. The Department and FDA now have determined that the seven types of Class 1 surgeon’s gloves and patient examination gloves listed in the 1/15 notice are reserved Class 1 devices for which a premarket notification is required. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-07-26/pdf/2021-15891.pdf?ref=fdaweb.com).