Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medigloves , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
352 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050181 | MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGIC | Medigloves , Ltd. | 2005-04-13 | 76 | 0 |
| K930795 | MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES | Medigloves , Ltd. | 1994-02-03 | 352 | 0 |
| K930794 | MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES | Medigloves , Ltd. | 1994-02-03 | 352 | 0 |
| K912157 | HYPOALLERGENIC SURGICAL LATEX GLOVES | Medigloves , Ltd. | 1991-09-06 | 113 | 0 |
| K912503 | HYPOALLERGENIC EXAMINATION LATEX GLOVES | Medigloves , Ltd. | 1991-09-06 | 113 | 0 |
| K891326 | PATIENT EXAMINATION GLOVES (LATEX) | Medigloves , Ltd. | 1989-09-13 | 184 | 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