Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shijiazhuang Winful Plastic Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K131341 | POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVE | Shijiazhuang Winful Plastic Co., Ltd. | 2014-02-06 | 273 | 0 |
| K043475 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COL | Shijiazhuang Winful Plastic Co., Ltd. | 2005-02-01 | 47 | 0 |
| K043477 | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORE | Shijiazhuang Winful Plastic Co., Ltd. | 2005-01-07 | 22 | 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