Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
50 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000071 | SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOV | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000-02-29 | 50 | 0 |
| K000166 | SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000-02-22 | 34 | 0 |
| K992861 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLO | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1999-10-06 | 42 | 0 |
| K983645 | SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998-12-04 | 49 | 0 |
| K983207 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998-10-30 | 46 | 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