Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Heze Juxinyuan Food Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102977 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COL | Heze Juxinyuan Food Co., Ltd. | 2010-12-20 | 75 | 0 |
| K102976 | POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLOR | Heze Juxinyuan Food Co., Ltd. | 2010-12-13 | 68 | 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