Durante Intl., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Durante Intl., Inc. makes
Durante Intl., Inc. manufactures ARISTA and ORIENT surgical gloves, designed for medical procedures, and coated isolation gowns intended for protective barrier use in healthcare settings.
The company’s products are regulated under FDA’s Class I and Class II device classifications and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Arista And Orient Surgical Gloves Ref K884633
510(k) 510(k)Coated Isolation Gown Ref K891677
510(k) 510(k)
Frequently asked questions
How many devices does Durante Intl., Inc. have in the registry?
The registry currently lists 2 devices for Durante Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Durante Intl., Inc.'s devices?
Among its 2 most recently registered devices, Durante Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Durante Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Durante Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Durante Intl., Inc. in the registry?
The most recently registered devices listed for Durante Intl., Inc. include ARISTA AND ORIENT SURGICAL GLOVES and COATED ISOLATION GOWN.