Synmertex Co, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Synmertex Co, Ltd.” (first 2003, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Synmertex Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032190 | DISPOSABLE POWDERED VINYL EXAM GLOVES | LYZ | 2003-08-14 | 28 |
| K032172 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | LYZ | 2003-08-14 | 29 |
| K031171 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES | LYZ | 2003-05-23 | 39 |
| K031120 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES | LYZ | 2003-05-23 | 45 |
| K031076 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR | LYZ | 2003-05-23 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Synmertex 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 Synmertex Co, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Synmertex Co, Ltd.” (first 2003, latest 2003), 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 Synmertex Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synmertex Co, Ltd. is 39 days.
Which FDA product codes appear under Synmertex Co, Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 5).
Next steps
- See all 5 Synmertex Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Synmertex 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.