Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Liwe Trading · 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) |
|---|---|---|---|---|---|
| K061505 | POWERED NITRILE BLUE EXAMINATION GLOVES | Liwe Trading | 2007-04-09 | 312 | 0 |
| K061504 | POWDER FREE NITRILE BLUE EXAMINATION GLOVE | Liwe Trading | 2007-03-19 | 291 | 0 |
| K933288 | POWDERFREE LATEX EXAMINATION GLOVES | Liwe Trading | 1994-08-17 | 407 | 0 |
| K913279 | LATEX EXAMINATION GLOVES | Liwe Trading | 1991-09-23 | 62 | 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