Clearance Summary
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE received FDA 510(k) clearance under submission number K012815, sponsored by Kimberly-Clark Corp.. 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 2001-11-13.
- Submission: K012815
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-11-13
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.