Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zibo Intco Medical Products Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132637 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | Zibo Intco Medical Products Co., Ltd. | 2014-05-01 | 251 | 0 |
| K132201 | SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE | Zibo Intco Medical Products Co., Ltd. | 2013-11-27 | 134 | 0 |
| K091942 | POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES | Zibo Intco Medical Products Co., Ltd. | 2009-09-21 | 83 | 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