Data / Medical devices / China / Zibo Shengkun Chemical Industry Co Ltd
Zibo Shengkun Chemical Industry Co Ltd: FDA-registered device maker in Zibo Shandong, China, 3 510(k) clearances
Zibo Shengkun Chemical Industry Co Ltd is registered with the FDA (registration 3009218271) in Zibo Shandong, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009218271
- Address
- Lot 6, No. 21 Qingtian Road Qilu Chemical Industrial Park, Zibo Shandong, China, 255414
- Owner or operator
- ZIBO SHENGKUN CHEMICAL INDUSTRY CO LTD (10038385)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 10, 2011
- Registered through
- 2026
- Brand names listed
- Customer's private label, Multiple Brand
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 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 7, 2025 | K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | LZA | Substantially Equivalent | Zibo Shengkun Chemical Industry Co., Ltd. | accessdata.fda.gov |
| September 21, 2011 | K111857 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Inmed Gloves Factory | accessdata.fda.gov |
| August 24, 2011 | K110621 | SHENGKUN CHEMICAL | LYZ | Substantially Equivalent | Zibo Shengkun Chemical Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2025. 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.