Hua Shu-Yee Industrial Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Hua Shu-Yee Industrial Co., Ltd. makes
Hua Shu-Yee Industrial Co., Ltd. manufactures latex examination gloves, which are single-use protective barriers designed for medical and clinical examinations to prevent cross-contamination between healthcare providers and patients.
The company’s latex examination gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Latex Examination Gloves Ref K893352
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hua Shu-Yee Industrial Co., Ltd. have in the registry?
The registry currently lists 1 device for Hua Shu-Yee Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hua Shu-Yee Industrial Co., Ltd.'s devices?
Among its 1 most recently registered device, Hua Shu-Yee Industrial Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hua Shu-Yee Industrial Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hua Shu-Yee Industrial Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hua Shu-Yee Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Hua Shu-Yee Industrial Co., Ltd. include LATEX EXAMINATION GLOVES.