Clearance Summary
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER received FDA 510(k) clearance under submission number K950995, sponsored by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1995-06-28.
- Submission: K950995
- Applicant / Sponsor: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1995-06-28
Classification & Regulation
This clearance is catalogued under FDA product code LYN and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.