Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Champion Plastic Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
58 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002218 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 | 22 | 0 |
| K002220 | NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 | 22 | 0 |
| K002217 | NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-11 | 18 | 0 |
| K002216 | NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-11 | 18 | 0 |
| K994136 | POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES | Shanghai Champion Plastic Products Co., Ltd. | 2000-02-03 | 58 | 0 |
| K994036 | PRE-POWDERED VINYL EXAM GLOVE, NON STERILE | Shanghai Champion Plastic Products Co., Ltd. | 1999-12-20 | 21 | 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