Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Tillotson Rubber 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) |
|---|---|---|---|---|---|
| K043014 | POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2005-01-28 | 87 | 0 |
| K042378 | NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLO | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2004-09-20 | 19 | 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