Clearance Summary
VINYL EXAM GLOVES, POWDER-FREE, YELLOW received FDA 510(k) clearance under submission number K031854, sponsored by Shanghai Jiawang Industrial Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-07-25.
- Submission: K031854
- Applicant / Sponsor: Shanghai Jiawang Industrial Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2003-07-25
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.