Glove One, LLC
Country not established
- Devices
- 1
What Glove One, LLC makes
Glove One, LLC manufactures powder-free nitrile examination gloves designed for medical use, including applications involving chemotherapy drugs and fentanyl. These non-sterile gloves are intended for single-use in clinical and procedural settings where barrier protection is required.
The company’s nitrile examination gloves fall under Class I regulatory classification in the U.S. and are listed via the FDA 510(k) pathway. The product is registered under U.S. jurisdiction.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glove One, LLC have in the registry?
The registry currently lists 1 device for Glove One, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glove One, LLC's devices?
Among its 1 most recently registered device, Glove One, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Glove One, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Glove One, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Glove One, LLC in the registry?
The most recently registered devices listed for Glove One, LLC include GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl].