Clearance Summary
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR received FDA 510(k) clearance under submission number K120798, sponsored by Canopus Medical Supply Co., Ltd.. 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 2012-05-14.
- Submission: K120798
- Applicant / Sponsor: Canopus Medical Supply Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2012-05-14
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.