Clearance Summary
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE received FDA 510(k) clearance under submission number K063581, sponsored by Pt Mahakarya Inti Buana. 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 2007-03-15.
- Submission: K063581
- Applicant / Sponsor: Pt Mahakarya Inti Buana
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2007-03-15
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.