Daxwell, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Daxwell, LLC makes
Daxwell, LLC manufactures powder-free vinyl patient examination gloves in clear, non-colored form for medical use. These gloves are designed for single-use in clinical examinations and procedures to reduce latex allergens and improve tactile sensitivity for healthcare providers.
The company’s product portfolio is regulated under FDA’s Class I device classification, requiring 510(k) clearance for market authorisation. The devices are listed in the FDA’s 510(k) database, adhering to US regulatory standards.
Catalogue
Powder Free Nitrile Examination Glove Ref K220834
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Daxwell, LLC have in the registry?
The registry currently lists 2 devices for Daxwell, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Daxwell, LLC's devices?
Among its 2 most recently registered devices, Daxwell, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Daxwell, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Daxwell, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Daxwell, LLC in the registry?
The most recently registered devices listed for Daxwell, LLC include Powder Free Nitrile Examination Glove and Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).