Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Junfei Plastic Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
104 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063471 | SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2007-02-28 | 104 | 0 |
| K062655 | POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2006-09-18 | 11 | 0 |
| K011474 | POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-05-31 | 17 | 0 |
| K010627 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-24 | 53 | 0 |
| K010626 | POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 | 52 | 0 |
| K010628 | POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 | 52 | 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