Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ansell Intl. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920745 | NUTEX GLOVES | Ansell Intl. | 1993-01-21 | 349 | 0 |
| K904244 | SENSIDERM | Ansell Intl. | 1991-02-06 | 145 | 0 |
| K904769 | SENSITOUCH | Ansell Intl. | 1991-01-28 | 98 | 0 |
| K895781 | ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES | Ansell Intl. | 1990-03-09 | 163 | 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