Seyen Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Seyen Intl., Inc. makes
Seyen Intl., Inc. manufactures single-use latex examination gloves designed for medical and clinical use, including general patient examinations and procedures requiring barrier protection.
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
Protex Latex Examination Gloves Ref K900933
Regimes: 510(k) Registry: 510(k)Protex Latex Examination Glove Ref K900790
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seyen Intl., Inc. have in the registry?
The registry currently lists 2 devices for Seyen Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seyen Intl., Inc.'s devices?
Among its 2 most recently registered devices, Seyen Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Seyen Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Seyen Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Seyen Intl., Inc. in the registry?
The most recently registered devices listed for Seyen Intl., Inc. include PROTEX LATEX EXAMINATION GLOVES and PROTEX LATEX EXAMINATION GLOVE.