Shandong Shangwei Medical Products Co., Ltd.
Registered establishment in Heze, Shandong, China. 3 device types, 2 clearances.
Shandong Shangwei Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Accessory, Surgical Apparel, Vinyl Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2020.
3device types registered with the FDA
2510(k) clearances
Registration
| Registered name | SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015477649 |
| FEI number | 3015477649 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Heze |
|---|---|
| Province | Shandong |
| Address | NORTH ROAD, FUMIN AVENUE,QINGHE STREET, |
| Postal code | 274400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable General Medical Face Mask(Non-Surgical) | 2020 | 439 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Nitrile Patient Examination Gloves, Blue Color | 2021 | 83 |
| Vinyl Patient Examination Glove | Class 1 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | 2021 | 72 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210779 | 2021-11-10 | LZA | Traditional | This company |
| K210780 | 2021-05-14 | LYZ | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | 65 |
| Shandong Haidike Medical Products Co., Ltd. | 22 |
| Coda Resources Ltd., Heze China | 9 |
| Shandong Caremed Medical Products Co., Ltd. | 6 |
| Biobase Medfuture Scientific Equipment Co., Ltd. | 5 |
| Shandong Jieshi Medical Products Co., Ltd. | 2 |
| Shandong Xiaokang Biotechnology Co., Ltd. | 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.