Zibo Intco Medical Products Company Limited
Registered establishment in Zibo, Shandong, China. 4 device types, 3 clearances.
Zibo Intco Medical Products Company Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Gown, Examination, Non-Surgical Gown and 2 other device types. Its earliest product listing with the FDA dates from 2009.
4device types registered with the FDA
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008191396 |
| FEI number | 3008191396 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | 18 Qingtian Road, Qilu Chem. Ind. Park, |
| Postal code | 255414 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shields | 2021 | 439 |
| Gown, Examination | Class 1 | Isolation Gown | 2020 | 109 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl Examination Glove, Powder Free,, Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue, Powder-Free Vinyl Patient Examination Gloves, Yellow Color | 2009 | 72 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K132637 | 2014-05-01 | LYZ | Traditional | This company |
| K132201 | 2013-11-27 | LYZ | Traditional | This company |
| K091942 | 2009-09-21 | LYZ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Employees | 13000 |
| Main products | Disposable gloves, Masks, Wheelchairs, Heat therapy products, Wound care |
| Certifications | FDA, 510(K), CE, NSF, BRC, CMDR |
| Export markets | 150+ countries |
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.