Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nitritex (M) 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) |
|---|---|---|---|---|---|
| K081970 | BIOCLEAN CHEMO SHIELD | Nitritex (M) Sdn. Bhd. | 2009-03-11 | 244 | 0 |
| K081971 | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINAT | Nitritex (M) Sdn. Bhd. | 2008-12-23 | 166 | 0 |
| K081972 | BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVE | Nitritex (M) Sdn. Bhd. | 2008-12-11 | 154 | 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