Shenyi (Shandong) Plastic Products Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Shenyi (Shandong) Plastic Products Co., Ltd. makes
Shenyi (Shandong) Plastic Products Co., Ltd. manufactures powder-free clear vinyl gloves designed for patient examinations. These gloves are intended to provide a clear view of the hands during medical procedures while maintaining barrier protection.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway in the United States. The manufacturer operates from the US, adhering to regulatory requirements for low-risk medical devices.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Shenyi Shandong Plastic Products Co Ltd Linzi Shandong · CN FEI 3011786252
Frequently asked questions
How many devices does Shenyi (Shandong) Plastic Products Co., Ltd. have in the registry?
The registry currently lists 1 device for Shenyi (Shandong) Plastic Products Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenyi (Shandong) Plastic Products Co., Ltd.'s devices?
Among its 1 most recently registered device, Shenyi (Shandong) Plastic Products Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shenyi (Shandong) Plastic Products Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shenyi (Shandong) Plastic Products Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Shenyi (Shandong) Plastic Products Co., Ltd. in the registry?
The most recently registered devices listed for Shenyi (Shandong) Plastic Products Co., Ltd. include Powder-free Clear Vinyl Patient Examination Gloves.
Which FDA establishments are linked to Shenyi (Shandong) Plastic Products Co., Ltd.?
1 FDA establishment is linked to Shenyi (Shandong) Plastic Products Co., Ltd. in the registry; they are listed on the company page.