Data / Medical devices / China / Shandong Shangwei Medical Products Co.,ltd
Shandong Shangwei Medical Products Co.,ltd: FDA-registered device maker in HEZE CITY Shandong, China, 2 510(k) clearances
Shandong Shangwei Medical Products Co.,ltd is registered with the FDA (registration 3015477649) in HEZE CITY Shandong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 10, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015477649
- Address
- North Road, Fumin Avenue,qinghe Street, Caoxian County, HEZE CITY Shandong, China, 274400
- Owner or operator
- SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD (10064517)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 25, 2020
- Registered through
- 2026
- Brand names listed
- Disposable General Medical Face Mask(Non-Surgical), Powder Free Nitrile Patient Examination Gloves, Blue Color, Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 10, 2021 | K210779 | Powder Free Nitrile Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Shandong Shangwei Medical Products Co., Ltd. | accessdata.fda.gov |
| May 14, 2021 | K210780 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | LYZ | Substantially Equivalent | Shandong Shangwei Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Accessory, Surgical Apparel
- All makers of Vinyl Patient Examination Glove
Updated November 10, 2021. 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.