American Nitrile Operations Llc
American Nitrile Operations Llc has 3 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-3289-2026 · Class II · Aug 14, 2026
- Latest 510(k)
- Jul 8, 2022
Reviewing American Nitrile Operations Llc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or get American Nitrile Operations Llc's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3289-2026 | Class II | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number… | Aug 14, 2026 |
| Z-3290-2026 | Class II | Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900… | Aug 14, 2026 |
| Z-3291-2026 | Class II | Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800… | Aug 14, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | Jul 8, 2022 |