Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asia Pacific Latex 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) |
|---|---|---|---|---|---|
| K033532 | ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATE | Asia Pacific Latex Sdn Bhd | 2004-01-28 | 79 | 0 |
| K033530 | ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION G | Asia Pacific Latex Sdn Bhd | 2004-01-28 | 79 | 0 |
| K982274 | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE | Asia Pacific Latex Sdn Bhd | 1998-08-11 | 43 | 0 |
| K924357 | LATEX PATIENT EXAMINATION GLOVES | Asia Pacific Latex Sdn Bhd | 1994-02-03 | 527 | 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