Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hubei Xinxin Non-Woven Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Su | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 | 213 | 0 |
| K214116 | AAMI4 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-10-11 | 285 | 0 |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-Woven Co., Ltd. | 2022-05-16 | 158 | 0 |
| K212120 | Surgical Masks | Hubei Xinxin Non-Woven Co., Ltd. | 2022-01-28 | 205 | 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