Data / Medical devices / China / Zibo Ling Yun Medical Products Co., Ltd.
Zibo Ling Yun Medical Products Co., Ltd.: FDA-registered device maker in Zibo Shandong, China, 2 510(k) clearances
Zibo Ling Yun Medical Products Co., Ltd. is registered with the FDA (registration 3012317628) in Zibo Shandong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 9, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012317628
- Address
- 318 Yuming Road, Zibo Shandong, China, 255400
- Owner or operator
- Zibo Ling Yun Medical Products Co., Ltd. (10051148)
- Roles
- Manufacturer
- First device listed
- February 8, 2016
- Registered through
- 2026
- Brand names listed
- Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Vinyl Exam Gloves, PF
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 |
|---|---|---|---|---|---|---|
| July 9, 2015 | K143340 | Powder Free Vinyl Patient Examination Gloves, Yellow Color | LYZ | Substantially Equivalent | Zibo Ling Yun Medical Products Co, Ltd. | accessdata.fda.gov |
| January 31, 2014 | K132221 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Haoyu Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 9, 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.