Sian-Yu Industrial Co., Ltd.
Country not established
- Devices
- 1
What Sian-Yu Industrial Co., Ltd. makes
Sian-Yu Industrial Co., Ltd. manufactures non-sterile vinyl examination gloves, designed for single-use medical and clinical applications. These gloves are intended to provide a barrier between healthcare providers and patients during procedures requiring hand protection.
The company’s vinyl examination gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States, adhering to applicable domestic regulatory standards for these products.
Catalogue
Non-Sterile Vinyl Examination Gloves Ref K892994
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sian-Yu Industrial Co., Ltd. have in the registry?
The registry currently lists 1 device for Sian-Yu Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sian-Yu Industrial Co., Ltd.'s devices?
Among its 1 most recently registered device, Sian-Yu Industrial Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sian-Yu Industrial Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sian-Yu Industrial Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sian-Yu Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Sian-Yu Industrial Co., Ltd. include NON-STERILE VINYL EXAMINATION GLOVES.