Data / Medical devices / China / Curon Scientific Co Ltd
Curon Scientific Co Ltd: FDA-registered device maker in WEIFANG Shandong, China, 2 510(k) clearances
Curon Scientific Co Ltd is registered with the FDA (registration 3008840959) in WEIFANG Shandong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008840959
- Address
- Lot 7, XINGAN ROAD EAST LINQU, WEIFANG Shandong, China, 262600
- Owner or operator
- CURON SCIENTIFIC CO LTD (10034281)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 18, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 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 |
|---|---|---|---|---|---|---|
| April 12, 2019 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | Substantially Equivalent | Shandong Hengya Packaging Printing Co.,Ltd | accessdata.fda.gov |
| November 8, 2010 | K102337 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE | LYZ | Substantially Equivalent | Curon Scientific Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 12, 2019. 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.