Clearance Summary
POWDER FREE VINYL PATIENT EXAMINATION GLOVE received FDA 510(k) clearance under submission number K112741, sponsored by Lifestyle Safty Products (Hui Zhou) 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 2012-09-13.
- Submission: K112741
- Applicant / Sponsor: Lifestyle Safty Products (Hui Zhou) Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2012-09-13
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.