Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gmp Medicare 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) |
|---|---|---|---|---|---|
| K250944 | Nitrile Powder Free Examination Glove, Blue Tested for Use w | Gmp Medicare Sdn. Bhd. | 2025-04-23 | 26 | 0 |
| K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use w | Gmp Medicare Sdn. Bhd. | 2021-02-24 | 219 | 0 |
| K163017 | Nitrile Blue Powder Free Examination Gloves with Low Dermati | Gmp Medicare Sdn. Bhd. | 2017-03-22 | 145 | 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