Clearance Summary
YULEX LATEX POWDER-FREE EXAM GLOVES received FDA 510(k) clearance under submission number K063810, sponsored by Yulex Corporation. 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 2008-04-18.
- Submission: K063810
- Applicant / Sponsor: Yulex Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2008-04-18
Classification & Regulation
This clearance is catalogued under FDA product code OIG and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.