Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sheen More Ent. Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
71 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013998 | POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES | Sheen More Ent. Co., Ltd. | 2002-02-13 | 71 | 0 |
| K001637 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR | Sheen More Ent. Co., Ltd. | 2000-06-23 | 24 | 0 |
| K001065 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR | Sheen More Ent. Co., Ltd. | 2000-05-23 | 50 | 0 |
| K001155 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR | Sheen More Ent. Co., Ltd. | 2000-05-23 | 43 | 0 |
| K000226 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR | Sheen More Ent. Co., Ltd. | 2000-03-02 | 35 | 0 |
| K992686 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR | Sheen More Ent. Co., Ltd. | 1999-09-24 | 45 | 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