Sheen More Ent. Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sheen More Ent. Co., Ltd.” (first 1999, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 44 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Sheen More Ent. Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013998 | POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES | LZA | 2002-02-13 | 71 |
| K001637 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR | LZA | 2000-06-23 | 24 |
| K001155 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR | LZA | 2000-05-23 | 43 |
| K001065 | DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR | LZA | 2000-05-23 | 50 |
| K000226 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR | LZA | 2000-03-02 | 35 |
| K992686 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR | LZA | 1999-09-24 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Sheen More Ent. Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sheen More Ent. Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Sheen More Ent. Co., Ltd.” (first 1999, latest 2002), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sheen More Ent. Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sheen More Ent. Co., Ltd. is 44 days.
Which FDA product codes appear under Sheen More Ent. Co., Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6).
Next steps
- See all 6 Sheen More Ent. Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Sheen More Ent. Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.