Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elite International, Inc. · 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) |
|---|---|---|---|---|---|
| K040071 | ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES W | Elite International, Inc. | 2004-06-03 | 141 | 0 |
| K032616 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES | Elite International, Inc. | 2003-10-02 | 38 | 0 |
| K031113 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | Elite International, Inc. | 2003-06-10 | 63 | 0 |
| K031134 | DISPOSABLE POWDERED VINYL EXAM GLOVES | Elite International, Inc. | 2003-05-20 | 41 | 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