Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Foremost Plastic Industrial 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) |
|---|---|---|---|---|---|
| K041041 | NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXA | Shanghai Foremost Plastic Industrial Co., Ltd. | 2004-06-08 | 47 | 0 |
| K032071 | POWDER FREE VINYL EXAMINATION GLOVE | Shanghai Foremost Plastic Industrial Co., Ltd. | 2003-10-10 | 99 | 0 |
| K971415 | VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE | Shanghai Foremost Plastic Industrial Co., Ltd. | 1997-05-23 | 36 | 0 |
| K971423 | VINYL PATIENT EXAMINATION GLOVE, POWDERED | Shanghai Foremost Plastic Industrial Co., Ltd. | 1997-05-23 | 36 | 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