Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Suqian Ruijang Medical Supplies 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) |
|---|---|---|---|---|---|
| K113194 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR | Suqian Ruijang Medical Supplies Co., Ltd. | 2012-05-14 | 196 | 0 |
| K113193 | PATIENT EXAMINATION GLOVE | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-12-16 | 46 | 0 |
| K113191 | POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-17 | 17 | 0 |
| K113195 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORE | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-16 | 16 | 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