Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Formosa Glove Industrial 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) |
|---|---|---|---|---|---|
| K014284 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWIS | Formosa Glove Industrial Co., Ltd. | 2002-02-15 | 50 | 0 |
| K014285 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE | Formosa Glove Industrial Co., Ltd. | 2002-02-14 | 49 | 0 |
| K992588 | BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | Formosa Glove Industrial Co., Ltd. | 1999-09-10 | 39 | 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