American Nitrile Operations, LLC
American Nitrile Operations, LLC holds FDA 510(k) medical device clearance, cleared in 2022, with 3 FDA device recalls on record.
Top product codes for American Nitrile Operations, LLC
FDA recalls by American Nitrile Operations, LLC
- Z-3289-2026 — Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
- Z-3290-2026 — Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves
- Z-3291-2026 — Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by American Nitrile Operations, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.