Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kab Gloves Unltd. — 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) |
|---|---|---|---|---|---|
| K900135 | CU-75 VISIBLE LIGHT-CURING UNIT | Kab Gloves Unltd. | 1990-05-07 | 117 | 0 |
| K900631 | SALIVA ABSORBER - DENTAL | Kab Gloves Unltd. | 1990-04-04 | 55 | 0 |
| K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. | 1990-04-03 | 88 | 0 |
| K900088 | MASKS SURGICAL DENTAL | Kab Gloves Unltd. | 1990-03-08 | 62 | 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