Success Builders Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Success Builders Intl., Inc. makes
Success Builders Intl., Inc. manufactures systems designed to improve the application and removal of latex gloves, including dedicated tools and glove models like the STAT(TM) Glove. These products are intended for use in clinical and procedural settings to enhance safety and efficiency during glove handling.
The company’s portfolio is classified under FDA’s Class I medical devices, with products listed via the 510(k) pathway. These devices are regulated under the US jurisdiction and are not subject to additional premarket approval requirements beyond the 510(k) clearance process.
Catalogue
Latex Glove Application And Removal System Ref K905127
Regimes: 510(k) Registry: 510(k)Stat(Tm) Glove Ref K905177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Success Builders Intl., Inc. have in the registry?
The registry currently lists 2 devices for Success Builders Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Success Builders Intl., Inc.'s devices?
Among its 2 most recently registered devices, Success Builders Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Success Builders Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Success Builders Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Success Builders Intl., Inc. in the registry?
The most recently registered devices listed for Success Builders Intl., Inc. include LATEX GLOVE APPLICATION AND REMOVAL SYSTEM and STAT(TM) GLOVE.