Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Matang Mfg. Sdn. Bhd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
211 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122131 | POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) | Matang Mfg. Sdn. Bhd. | 2012-10-17 | 91 | 0 |
| K121368 | NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE | Matang Mfg. Sdn. Bhd. | 2012-08-10 | 95 | 0 |
| K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATI | Matang Mfg. Sdn. Bhd. | 2008-04-15 | 211 | 0 |
| K032549 | MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVE | Matang Mfg. Sdn. Bhd. | 2003-09-08 | 21 | 0 |
| K012558 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA | Matang Mfg. Sdn. Bhd. | 2001-09-17 | 40 | 0 |
| K000985 | MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN | Matang Mfg. Sdn. Bhd. | 2000-04-24 | 28 | 0 |
| K982877 | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLO | Matang Mfg. Sdn. Bhd. | 1998-11-30 | 108 | 0 |
| K896094 | LATEX EXAMINATION GLOVES | Matang Mfg. Sdn. Bhd. | 1990-01-17 | 89 | 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