Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Semperit Investments Asia Pte , Ltd. · 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) |
|---|---|---|---|---|---|
| K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue | Semperit Investments Asia Pte , Ltd. | 2023-01-27 | 30 | 0 |
| K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored | Semperit Investments Asia Pte , Ltd. | 2019-10-04 | 296 | 0 |
| K171378 | Non-Sterile, Single use, Powder-free examination glove teste | Semperit Investments Asia Pte , Ltd. | 2017-09-14 | 127 | 0 |
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber | Semperit Investments Asia Pte , Ltd. | 2017-05-02 | 406 | 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