Sunmax Enterprise Shanghai Co., Ltd.
Country not established
- Devices
- 5
What Sunmax Enterprise Shanghai Co., Ltd. makes
Sunmax Enterprise Shanghai Co., Ltd. manufactures single-use patient examination gloves, including powdered and powder-free versions made from vinyl and nitrile. Their products are designed for medical and healthcare settings, with some formulations tested for compatibility with chemotherapy drugs. The gloves are intended for use during procedures requiring barrier protection, such as physical examinations and medical treatments.
The company’s portfolio consists of Class I medical devices, which are generally considered low-risk. These products are listed under the FDA’s 510(k) pathway, indicating they meet regulatory requirements for marketing in the United States. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Powder-Free Vinyl Patient Examination Gloves Ref K964964
Regimes: 510(k) Registry: 510(k)Sunmax Blue Nitrile Powdered Examination Gloves Ref K011717
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sunmax Enterprise Shanghai Co., Ltd. have in the registry?
The registry currently lists 5 devices for Sunmax Enterprise Shanghai Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sunmax Enterprise Shanghai Co., Ltd.'s devices?
Among its 5 most recently registered devices, Sunmax Enterprise Shanghai Co., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sunmax Enterprise Shanghai Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sunmax Enterprise Shanghai Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sunmax Enterprise Shanghai Co., Ltd. in the registry?
The most recently registered devices listed for Sunmax Enterprise Shanghai Co., Ltd. include SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES, POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES and SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS.