Data / Medical devices / China / Shijiazhuang Wally Plastic Co.,ltd
Shijiazhuang Wally Plastic Co.,ltd: FDA-registered device maker in Shijiazhuang Hebei, China, 3 510(k) clearances
Shijiazhuang Wally Plastic Co.,ltd is registered with the FDA (registration 3003896660) in Shijiazhuang Hebei, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 30, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003896660
- Address
- Main Site: No.78 Tongda Road, Jinzhou City, 052260 Hebei, P. R. China Additional site: South of Weiwu Road, West of Jingsan Street, Jinzhou Economic Development Zone, 052260 Hebei, Shijiazhuang Hebei, China, 052260
- Owner or operator
- shijiazhuang wally plastic co.,ltd (10027895)
- Roles
- Manufacturer
- First device listed
- December 11, 2008
- Registered through
- 2026
- Brand names listed
- Wally, exam gloves
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 30, 2014 | K131344 | POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shijiazhuang Wally Plastics Co., Ltd. | accessdata.fda.gov |
| August 31, 2004 | K041379 | PRE-POWDERED VINYL EXAM GLOVES | LYZ | Substantially Equivalent | Shijiazhuang Wally Plastics Co., Ltd. | accessdata.fda.gov |
| September 16, 2002 | K022600 | POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shijiazhuang Wally Plastics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 2014. 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.