Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Primus Gloves Pvt Limited · 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) |
|---|---|---|---|---|---|
| K170612 | STERILE VINYL EXAMINATION GLOVES, Powder Free | Primus Gloves Pvt Limited | 2017-10-23 | 236 | 0 |
| K170515 | Sterile Nitrile Surgical Gloves, Powder-free | Primus Gloves Pvt Limited | 2017-06-09 | 108 | 0 |
| K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | Primus Gloves Pvt Limited | 2016-04-14 | 496 | 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