Clearance Summary
UNIJECT SURGICAL GLOVES received FDA 510(k) clearance under submission number K970160, sponsored by Uniject Gloves , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1997-07-15.
- Submission: K970160
- Applicant / Sponsor: Uniject Gloves , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1997-07-15
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.