Data / Medical devices / China / Hebei Grandeast Plastic Products Co Ltd
Hebei Grandeast Plastic Products Co Ltd: FDA-registered device maker in Xingtai Hebei, China, 1 510(k) clearance
Hebei Grandeast Plastic Products Co Ltd is registered with the FDA (registration 3011586620) in Xingtai Hebei, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 15, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011586620
- Address
- Industrial Park, Julu County, Xingtai Hebei, China, 055250
- Owner or operator
- Hebei Grandeast Plastic Products Co Ltd (10048549)
- Roles
- Manufacturer
- First device listed
- January 26, 2015
- Registered through
- 2026
- Brand names listed
- Vinyl patient examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| January 15, 2015 | K142703 | Powder-free PVC Vinyl Exam Gloves | LYZ | Substantially Equivalent | Hebei Grandeast Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 15, 2015. 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.