Data / Medical devices / Vietnam / Star Investment And Trade Joint Stock Company
Star Investment And Trade Joint Stock Company: FDA-registered device maker in Bac Ninh, Vietnam, 1 510(k) clearance
Star Investment And Trade Joint Stock Company is registered with the FDA (registration 3017940518) in Bac Ninh, Vietnam. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017940518
- Address
- Ba Huyen Quarter, Khac Niem Ward, Bac Ninh, Vietnam, 790000
- Owner or operator
- STAR INVESTMENT AND TRADE JOINT STOCK COMPANY (10080105)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 12, 2021
- Registered through
- 2026
- Brand names listed
- Latex Patient Examination Glove, O'Star Nitrile Examination Gloves Powder Free, Vinyl Patient Examination Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 8, 2022 | K213058 | O'Star Nitrile Examination Gloves Powder Free | LZA | Substantially Equivalent | Star Investment and Trade Joint Stock Company | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
Updated February 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.