Suzhou Shengyuda Plastic Products Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 2
What Suzhou Shengyuda Plastic Products Co., Ltd. makes
The company manufactures single-use patient examination gloves made from powdered and powder-free vinyl, intended for medical and clinical procedures. These gloves are designed for clear visibility of hands and are non-colored to ensure compatibility with various diagnostic and treatment applications.
The portfolio consists of Class I medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the U.S. regulatory database and comply with applicable U.S. standards for patient examination gloves.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Suzhou Shengyuda Plastic Products Co., Ltd. have in the registry?
The registry currently lists 2 devices for Suzhou Shengyuda Plastic Products Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Shengyuda Plastic Products Co., Ltd.'s devices?
Among its 2 most recently registered devices, Suzhou Shengyuda Plastic Products Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Suzhou Shengyuda Plastic Products Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Suzhou Shengyuda Plastic Products Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Shengyuda Plastic Products Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Shengyuda Plastic Products Co., Ltd. include POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) and POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED).