Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wuhan Zonsen Medical Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
236 daysmedian FDA review time
396 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | 2023-08-25 | 266 | 0 |
| K213601 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2022-12-16 | 396 | 0 |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | Wuhan Zonsen Medical Products Co., Ltd. | 2022-02-18 | 87 | 0 |
| K212357 | Surgical isolation gown | Wuhan Zonsen Medical Products Co., Ltd. | 2022-01-20 | 175 | 0 |
| K212861 | Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. | 2021-12-15 | 98 | 0 |
| K202191 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2021-03-29 | 236 | 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