Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Primus Gloves Private , Ltd. · 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) |
|---|---|---|---|---|---|
| K030445 | POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND P | Primus Gloves Private , Ltd. | 2003-06-05 | 114 | 0 |
| K030444 | PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES | Primus Gloves Private , Ltd. | 2003-06-05 | 114 | 0 |
| K021065 | PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/G | Primus Gloves Private , Ltd. | 2002-05-08 | 36 | 0 |
| K020044 | VINYL EXAMINATION GLOVES STERILE POWEDERED | Primus Gloves Private , Ltd. | 2002-02-26 | 50 | 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