Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nephron Nitrile, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Bla | Nephron Nitrile, LLC | 2024-03-20 | 202 | 0 |
| K233970 | Nephron Nitrile™, Nitrile Powder-Free Examination Blue Glove | Nephron Nitrile, LLC | 2024-01-16 | 32 | 0 |
| K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Test | Nephron Nitrile, LLC | 2023-06-06 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda