Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gmp Medicare Sdn Bhd (F25) · 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) |
|---|---|---|---|---|---|
| K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitr | Gmp Medicare Sdn Bhd (F25) | 2019-08-29 | 363 | 0 |
| K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examin | Gmp Medicare Sdn Bhd (F25) | 2018-05-10 | 232 | 0 |
| K152222 | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use w | Gmp Medicare Sdn Bhd (F25) | 2016-04-21 | 258 | 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