Shandong Intco Medical Products Co Ltd
Registered establishment in Qingzhou, Shandong, China. 6 device types, 4 clearances.
Shandong Intco Medical Products Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Medical Glove, Specialty and 4 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | SHANDONG INTCO MEDICAL PRODUCTS CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011391433 |
| FEI number | 3011391433 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Qingzhou |
|---|---|
| Province | Shandong |
| Address | 9888 Qiwang Road |
| Postal code | 262500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Electrocardiograph | Class 2 | Electrode, electrocardiograph | 2025 | 33 |
| Latex Patient Examination Glove | Class 1 | Latex Examination Gloves, Sterile Latex Examination Gloves Powder Free | 2026 | 12 |
| Mask, Surgical | Class 2 | Medical face mask | 2021 | 125 |
| Medical Glove, Specialty | Class 1 | nitrile examination glove | 2018 | 48 |
| Polymer Patient Examination Glove | Class 1 | nitrile examination glove | 2016 | 83 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl examination glove | 2021 | 72 |
Clearances
4 clearances name Shandong Intco Medical Products Co Ltd as applicant. 3 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 |
|---|---|---|---|---|
| K233042 | 2023-12-06 | LZA | Traditional | This company |
| K231408 | 2023-08-11 | LZA | Traditional | This company |
| K223298 | 2023-02-22 | LYY | Traditional | This company |
| K213509 | 2022-04-08 | LYY | Traditional | This company |
| K202708 | 2021-03-30 | FXX | Traditional | Intco Medical(Hk) Co., Ltd. |
| K170136 | 2017-08-25 | LZA | Traditional | Shandong Feiyang Professional Gloves Co., Ltd. |
| K131832 | 2014-01-07 | LYZ | Traditional | Shandong Binxiang Medical Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1990s |
|---|---|
| Main products | nitrile gloves, latex gloves, vinyl gloves, synthetic gloves |
| Certifications | ASTM, TUV, FDA 510K, ISO 9001, CE, BRC |
| Export markets | 150+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Zhiyuan Medical Product Co Ltd | 1 |
| Shandong Zhanpeng Medical Products Company Limited | 1 |
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.