Data / Medical devices / China / Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.: FDA-registered device maker in Shijiazhuang Hebei, China, 1 510(k) clearance
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. is registered with the FDA (registration 3017953728) in Shijiazhuang Hebei, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 17, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017953728
- Address
- Xinye Industrial Zone, Wangtong Village,Wancheng Town, Gaoyi County, Shijiazhuang Hebei, China, 051330
- Owner or operator
- Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. (10079469)
- Roles
- Manufacturer
- First device listed
- September 15, 2021
- Registered through
- 2026
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 17, 2021 | K211177 | Powder Free Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 17, 2021. 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.