Sunmax Enterprise Shanghai Co. , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sunmax Enterprise Shanghai Co. , Ltd.” (first 1996, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 | 3 | 3 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Sunmax Enterprise Shanghai Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090336 | SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | LZA | 2009-07-01 | 141 |
| K011765 | SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE | LZA | 2001-08-16 | 70 |
| K011717 | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES | LZA | 2001-08-14 | 71 |
| K964964 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 1997-02-07 | 58 |
| K960746 | SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES | LYZ | 1996-06-27 | 125 |
Recalls
openFDA lists no recalls under a recalling firm named Sunmax Enterprise Shanghai 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sunmax Vietnam Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sunmax Enterprise Shanghai Co. , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Sunmax Enterprise Shanghai Co. , Ltd.” (first 1996, latest 2009), across 2 product codes 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 Sunmax Enterprise Shanghai Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunmax Enterprise Shanghai Co. , Ltd. is 71 days.
Which FDA product codes appear under Sunmax Enterprise Shanghai Co. , Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 3); LYZ (Vinyl Patient Examination Glove, 2).
Next steps
- See all 5 Sunmax Enterprise Shanghai Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Sunmax Enterprise Shanghai 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.