Oak Carolina, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Oak Carolina, Inc. makes
Oak Carolina, Inc. manufactures single-use examination gloves, including vinyl and textured variants designed for patient contact during medical procedures. Their product line includes standard examination gloves and specialized versions like the OakTex line, which features enhanced tactile sensitivity for precise medical assessments.
These gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company’s products are intended for use in the United States, where they comply with applicable FDA requirements for low-risk devices.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sensitex Examination Glove Ref K981963
Regimes: 510(k) Registry: 510(k)Glove, Examination, Vinyl Ref K952050
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oak Carolina, Inc. have in the registry?
The registry currently lists 3 devices for Oak Carolina, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oak Carolina, Inc.'s devices?
Among its 3 most recently registered devices, Oak Carolina, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Oak Carolina, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Oak Carolina, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Oak Carolina, Inc. in the registry?
The most recently registered devices listed for Oak Carolina, Inc. include GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION, SENSITEX EXAMINATION GLOVE and GLOVE, EXAMINATION, VINYL.