Jen I Hardware Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Jen I Hardware Co., Ltd. makes
Jen I Hardware Co., Ltd. manufactures latex patient examination gloves, designed for single-use medical procedures requiring barrier protection.
These gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K892572
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Jen I Hardware Co., Ltd. have in the registry?
The registry currently lists 1 device for Jen I Hardware Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jen I Hardware Co., Ltd.'s devices?
Among its 1 most recently registered device, Jen I Hardware Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Jen I Hardware Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Jen I Hardware Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Jen I Hardware Co., Ltd. in the registry?
The most recently registered devices listed for Jen I Hardware Co., Ltd. include PATIENT EXAMINATION GLOVES (LATEX).