Regent Medical Americas, LLC
United StatesFDA applicant, unverified
- Devices
- 7
What Regent Medical Americas, LLC makes
The company manufactures sterile surgeon’s gloves and powder-free non-latex gloves, including poly-isoprene variants designed for medical and surgical use. Products are marketed as latex powder-free, non-pyrogenic, and intended for single-use in clinical settings.
These devices are classified as Class I under FDA regulations and are supported by 510(k) clearances. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Biogel Latex Powder Free Sterile Surgeon's Glove Ref K053441
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Biogel Latex Sterile Powder-Free Glove Ref K050899
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Regent Medical Americas, LLC have in the registry?
The registry currently lists 7 devices for Regent Medical Americas, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regent Medical Americas, LLC's devices?
Among its 7 most recently registered devices, Regent Medical Americas, LLC has devices listed in FDA 510(k) (7 devices).
What risk classes do Regent Medical Americas, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Regent Medical Americas, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Regent Medical Americas, LLC in the registry?
The most recently registered devices listed for Regent Medical Americas, LLC include BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE, BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE, BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE and BIOGEL LATEX STERILE POWDER-FREE GLOVE.