Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kenwell International , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
120 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980412 | COLOURED POWDWR-FREE SURGICAL GLOVES | Kenwell International , Ltd. | 1998-04-08 | 64 | 0 |
| K980803 | STERILE POWDER-FREE LATEX EXAMINATION GLOVES | Kenwell International , Ltd. | 1998-04-03 | 32 | 0 |
| K963020 | GLOVEL GX | Kenwell International , Ltd. | 1996-11-27 | 114 | 0 |
| K911134 | SURGICAL GLOVES | Kenwell International , Ltd. | 1991-07-12 | 120 | 0 |
| K900811 | LATEX PATIENT EXAMINATION GLOVES | Kenwell International , Ltd. | 1990-03-09 | 16 | 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