Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xingyu Medical Tech 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) |
|---|---|---|---|---|---|
| K240629 | Nitrile Disposable Examination Gloves, Tested for Use with C | Xingyu Medical Tech Co., Ltd. | 2024-05-28 | 83 | 0 |
| K221273 | Medical Face Mask (M001) | Xingyu Medical Tech Co., Ltd. | 2022-06-28 | 57 | 0 |
| K212735 | Nitrile disposable examination gloves (Tested for use with C | Xingyu Medical Tech Co., Ltd. | 2022-01-11 | 134 | 0 |
| K212578 | Nitrile disposable examination gloves | Xingyu Medical Tech Co., Ltd. | 2021-12-02 | 108 | 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