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# Latex Gloves Need 510(k); More Surveillance
- URL: https://www.fdaweb.com/latex-gloves-need-510-k-more-surveillance/
- Published: 2021-04-16T12:00:00.000Z
- Updated: 2026-09-14T16:55:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149128

*Federal Register* notice: FDA is clarifiying that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examination gloves will continue to require premarket notification. Furthermore, because of the potential risks posed by gloves that have not undergone FDA’s premarket review, FDA intends to increase surveillance on the gloves. The agency says the increased surveillance could, for example, include a labeling review and a physical examination to assess for physical defects. Because most gloves are imported, FDA’s focus will be on products at the time of importation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-04-16/pdf/2021-07759.pdf?ref=fdaweb.com).