American Gemini, Inc.
Country not established
- Devices
- 1
What American Gemini, Inc. makes
American Gemini, Inc. manufactures powder-free vinyl examination gloves designed for medical and clinical use, intended to reduce powder-related risks during procedures.
The company’s products are regulated under FDA’s Class I device classification and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Vinyl Examination Glove, Powder-Free Ref K944510
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Gemini, Inc. have in the registry?
The registry currently lists 1 device for American Gemini, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Gemini, Inc.'s devices?
Among its 1 most recently registered device, American Gemini, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do American Gemini, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for American Gemini, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from American Gemini, Inc. in the registry?
The most recently registered devices listed for American Gemini, Inc. include VINYL EXAMINATION GLOVE, POWDER-FREE.