Clearance Summary
SENSITEX EXAMINATION GLOVE received FDA 510(k) clearance under submission number K981963, sponsored by Oak Carolina, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-07-24.
- Submission: K981963
- Applicant / Sponsor: Oak Carolina, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1998-07-24
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.