Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Long First (Xiamen) 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) |
|---|---|---|---|---|---|
| K031170 | POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHIT | Long First (Xiamen) Co., Ltd. | 2003-11-13 | 213 | 0 |
| K991085 | BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES | Long First (Xiamen) Co., Ltd. | 1999-05-05 | 36 | 0 |
| K990946 | BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES | Long First (Xiamen) Co., Ltd. | 1999-05-04 | 43 | 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