Data / Medical devices / Thailand / ZOUPURE MEDIC Co., Ltd.
ZOUPURE MEDIC Co., Ltd.: FDA-registered device maker in Ban Khai Rayong, Thailand, 1 510(k) clearance
ZOUPURE MEDIC Co., Ltd. is registered with the FDA (registration 3023191174) in Ban Khai Rayong, Thailand. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023191174
- Address
- 168 Moo 1 Nong Bua, Ban Khai Rayong, Thailand, 21120
- Owner or operator
- Zoupure Medic Co., Ltd. (10085422)
- Roles
- Manufacturer
- First device listed
- June 15, 2022
- Registered through
- 2026
- Brand names listed
- Zoupure 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 |
|---|---|---|---|---|---|---|
| June 7, 2022 | K220693 | Zoupure Nitrile Powder Free Examination glove | LZA | Substantially Equivalent | Thai Rayong Product Glove Zoupure Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 7, 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.