Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zibo Sinocare Plastic Products Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use Wi | Zibo Sinocare Plastic Products Co., Ltd. | 2022-02-18 | 137 | 0 |
| K051723 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) | Zibo Sinocare Plastic Products Co., Ltd. | 2005-07-15 | 18 | 0 |
| K051148 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Zibo Sinocare Plastic Products Co., Ltd. | 2005-06-21 | 48 | 0 |
| K051152 | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORE | Zibo Sinocare Plastic Products Co., Ltd. | 2005-06-03 | 30 | 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