Gri Medical & Electrical Technology Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 3
What Gri Medical & Electrical Technology Co., Ltd. makes
Gri Medical & Electrical Technology Co., Ltd. manufactures surgical gowns designed for medical procedures, including the ComfortGuard Plus, ComfortGuard, and RoyalGuard series. These gowns feature variations such as breathable fabric, reinforced film, and specific barrier performance ratings (i500, i600). The products are intended for use in surgical environments to provide fluid resistance and comfort.
The company’s surgical gowns fall under Class II regulatory classification in the US and are recorded in the FDA 510(k) database. These devices are subject to premarket notification requirements under US medical device regulations. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
RoyalGuard Surgical Gown, i600, Breathable Ref K172445
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gri Medical & Electrical Technology Co., Ltd. have in the registry?
The registry currently lists 3 devices for Gri Medical & Electrical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gri Medical & Electrical Technology Co., Ltd.'s devices?
Among its 3 most recently registered devices, Gri Medical & Electrical Technology Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gri Medical & Electrical Technology Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gri Medical & Electrical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gri Medical & Electrical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Gri Medical & Electrical Technology Co., Ltd. include ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500, RoyalGuard Surgical Gown, i600, Breathable and ComfortGuard Surgical Gown, i600, Film Reinforced.