Data / Medical devices / China / Shandong Zhiyuan Medical Product Co Ltd
Shandong Zhiyuan Medical Product Co Ltd: FDA-registered device maker in Qingzhou Shandong, China, 3 510(k) clearances
Shandong Zhiyuan Medical Product Co Ltd is registered with the FDA (registration 3009741833) in Qingzhou Shandong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 5, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009741833
- Address
- 20 Shengshui Rd. Mihe Industry Park, Qingzhou Shandong, China, 262519
- Owner or operator
- Shandong Zhiyuan Medical Product Co Ltd (10041789)
- Roles
- Manufacturer
- First device listed
- August 31, 2012
- Registered through
- 2026
- Brand names listed
- Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Synthetic Vinyl Patient Examination Gloves -- Powder Free
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 |
|---|---|---|---|---|---|---|
| February 5, 2016 | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue | LYZ | Substantially Equivalent | Zibo Huiying Medical Products, Co. , Ltd. | accessdata.fda.gov |
| May 8, 2012 | K112266 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Shandong Zhiyuan Medical Products Co., Ltd. | accessdata.fda.gov |
| November 22, 2010 | K102444 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Yingbo Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 5, 2016. 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.