Data / Medical devices / China / Shenyi Shandong Plastic Products Co Ltd
Shenyi Shandong Plastic Products Co Ltd: FDA-registered device maker in Linzi Shandong, China, 3 510(k) clearances
Shenyi Shandong Plastic Products Co Ltd is registered with the FDA (registration 3011786252) in Linzi Shandong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 25, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011786252
- Address
- 23 Fenghuang Road,Fengshan Industry Park, Linzi Shandong, China, 255400
- Owner or operator
- Shenyi Shandong Plastic Products Co Ltd (10049482)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 5, 2015
- Registered through
- 2026
- Brand names listed
- Vinyl Exam Gloves, PF, Vinyl patient examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 25, 2015 | K142892 | Powder-free Clear Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Shenyi (Shandong) Plastic Products Co., Ltd. | accessdata.fda.gov |
| January 7, 2014 | K131832 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Binxiang Medical Products Co., Ltd. | accessdata.fda.gov |
| September 21, 2009 | K091942 | POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Intco Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 25, 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.