Data / Medical devices / Vietnam / Binh An Medical Co., Ltd
Binh An Medical Co., Ltd: FDA-registered device maker in Dong Trieu Township, Quang Ninh, Vietnam, 1 510(k) clearance
Binh An Medical Co., Ltd is registered with the FDA (registration 3020106122) in Dong Trieu Township, Quang Ninh, Vietnam. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 18, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020106122
- Address
- No. 437, Kim Son Ward, Dong Trieu Township, Quang Ninh, Vietnam, 20000
- Owner or operator
- BINH AN MEDICAL CO., LTD (10091993)
- Roles
- Exporter to the US
- First device listed
- November 22, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 18, 2009 | K090520 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2009. 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.