Zibo Shengkun Chemical Industry Co Ltd
Manufacturer and brand owner in Zibo, Shandong, China. 2 device types, 2 products catalogued, 1 clearance.
Zibo Shengkun Chemical Industry Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Vinyl Patient Examination Glove, Polymer Patient Examination Glove. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | ZIBO SHENGKUN CHEMICAL INDUSTRY CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009218271 |
| FEI number | 3009218271 |
| DUNS | 528106527 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | Lot 6, No. 21 Qingtian Road |
| Postal code | 255414 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Polymer Patient Examination Glove | Class 1 | 2025 | 83 | |
| Vinyl Patient Examination Glove | Class 1 | Multiple Brand, Customer’s private label | 2011 | 72 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Polymer Patient Examination Glove | LZA | 8 |
| Shengkun | LZA | 1 |
Clearances
1 clearance names Zibo Shengkun Chemical Industry Co Ltd as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250496 | 2025-07-07 | LZA | Traditional | This company |
| K111857 | 2011-09-21 | LYZ | Traditional | Inmed Gloves Factory |
| K110621 | 2011-08-24 | LYZ | Traditional | Zibo Shengkun Chemical Industrial Co., Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.