Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972838 | POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE O | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-08-15 | 14 | 0 |
| K972177 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLOR | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 | 49 | 0 |
| K972195 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-CO | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 | 48 | 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