Clearance Summary
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR received FDA 510(k) clearance under submission number K051393, sponsored by Ever Global Enterprise Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-07-27.
- Submission: K051393
- Applicant / Sponsor: Ever Global Enterprise Corporation
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2005-07-27
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.