Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quality Gallant 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) |
|---|---|---|---|---|---|
| K092874 | POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | 2010-06-22 | 277 | 0 |
| K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | 2008-12-03 | 180 | 0 |
| K071322 | POWDER FREE LATEX EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | 2007-07-13 | 64 | 0 |
| K071323 | POWDERED LATEX EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | 2007-06-22 | 43 | 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