Clearance Summary
DISPOSABLE VINYL EXAM GLOVE, POWDERED received FDA 510(k) clearance under submission number K113790, sponsored by Full Synergy Medical Products, Inc.. 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 2012-03-06.
- Submission: K113790
- Applicant / Sponsor: Full Synergy Medical Products, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2012-03-06
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.