Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Eversharp Plastic Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
29 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031293 | SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FR | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2003-05-09 | 16 | 0 |
| K011883 | POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 | 29 | 0 |
| K011884 | POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 | 29 | 0 |
| K011885 | SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-16 | 28 | 0 |
| K011882 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLO | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-10 | 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