Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Masju Sdn. Bhd. · 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) |
|---|---|---|---|---|---|
| K991493 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | Masju Sdn. Bhd. | 1999-05-26 | 28 | 0 |
| K980150 | POWDER-FREE NITRILE EXAMINATION GLOVES | Masju Sdn. Bhd. | 1998-02-09 | 24 | 0 |
| K980149 | POWDERED NITRILE EXAMINATION GLOVES | Masju Sdn. Bhd. | 1998-01-29 | 13 | 0 |
| K892953 | PATIENT EXAMINATION GLOVES | Masju Sdn. Bhd. | 1989-09-13 | 154 | 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