Clearance Summary
MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM received FDA 510(k) clearance under submission number K932061, sponsored by Advanced Chemical Technology, 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 1993-11-16.
- Submission: K932061
- Applicant / Sponsor: Advanced Chemical Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1993-11-16
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.