Clearance Summary
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE received FDA 510(k) clearance under submission number K980942, sponsored by London International Group, Inc.. 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 1998-05-11.
- Submission: K980942
- Applicant / Sponsor: London International Group, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1998-05-11
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.