Clearance Summary
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE received FDA 510(k) clearance under submission number K101870, sponsored by Sunmax Vietnam 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 2010-12-20.
- Submission: K101870
- Applicant / Sponsor: Sunmax Vietnam Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.