Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Starmatrix 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) |
|---|---|---|---|---|---|
| K023715 | STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEI | Starmatrix Sdn Bhd | 2003-02-04 | 91 | 0 |
| K023978 | NITRILE EXAMINATION GLOVES, POWDER FREE | Starmatrix Sdn Bhd | 2003-01-24 | 53 | 0 |
| K023979 | NITRILE EXAMINATION GLOVES, PRE-POWDERED | Starmatrix Sdn Bhd | 2003-01-24 | 53 | 0 |
| K023977 | PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING | Starmatrix Sdn Bhd | 2003-01-24 | 53 | 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