Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Xuchang Zhengde Environstar Medical Products 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) |
|---|---|---|---|---|---|
| K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 | 372 | 0 |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with R | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020-04-30 | 251 | 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