Data / Medical devices / Vietnam / Ecoglove Medical Manufacturing Company Limited
Ecoglove Medical Manufacturing Company Limited: FDA-registered device maker in Bau Bang Commune Ho Chi Minh, Vietnam, 1 510(k) clearance
Ecoglove Medical Manufacturing Company Limited is registered with the FDA (registration 3021640893) in Bau Bang Commune Ho Chi Minh, Vietnam. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021640893
- Address
- A part of land plot No. 679, map No. 41, N4 Street, Bau Bang Hamlet, Bau Bang Commune Ho Chi Minh, Vietnam, 75706
- Owner or operator
- ECOGLOVE MEDICAL MANUFACTURING COMPANY LIMITED (10084076)
- Roles
- Manufacturer
- First device listed
- December 30, 2024
- Registered through
- 2026
- Brand names listed
- Powder Free Nitrile Examination Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 16, 2023 | K222813 | Nitrile Examination Gloves | LZA | Substantially Equivalent | Ecoglove Medical Manufacturing Company Limited | accessdata.fda.gov |
Compare with other makers
Updated March 16, 2023. 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.