Guardian Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Guardian Group, Inc. makes
Guardian Group, Inc. manufactures disposable nitrile examination gloves, including the Guardian II Glove and the Guardian Glove, designed for medical and clinical use to provide barrier protection during procedures.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Guardian Ii Glove Ref K945577
Regimes: 510(k) Registry: 510(k)Guardian Glove Ref K942313
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Guardian Group, Inc. have in the registry?
The registry currently lists 2 devices for Guardian Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guardian Group, Inc.'s devices?
Among its 2 most recently registered devices, Guardian Group, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Guardian Group, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Guardian Group, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Guardian Group, Inc. in the registry?
The most recently registered devices listed for Guardian Group, Inc. include GUARDIAN II GLOVE and GUARDIAN GLOVE.