Edma Group, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Edma Group, LLC makes
Edma Group, LLC manufactures single-use nitrile examination gloves, including variants tested for compatibility with chemotherapy drugs. These gloves are designed for medical and clinical use to provide barrier protection during procedures requiring sterile or clean hand hygiene.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The manufacturer operates from the United States, adhering to applicable regulatory standards for these categories.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Edma Synthetic Nitrile Examination Gloves Ref K211540
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edma Group, LLC have in the registry?
The registry currently lists 2 devices for Edma Group, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edma Group, LLC's devices?
Among its 2 most recently registered devices, Edma Group, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Edma Group, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Edma Group, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Edma Group, LLC in the registry?
The most recently registered devices listed for Edma Group, LLC include Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) and Edma Synthetic Nitrile Examination Gloves.