FDA applicant
American Nitrile Operations, LLC
FDA records 1 decision for American Nitrile Operations, LLC (Grove City, OH) in 2022: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Nitrile Operations, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
3in 2026
Class I Class II/III not classified
Planning a device like American Nitrile Operations, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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