Clearance Summary
POWDER-FREE NITRILE EXAM GLOVE, BLUE received FDA 510(k) clearance under submission number K011286, sponsored by Ningbo Yujiang Plastic & Rubber 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 2001-05-16.
- Submission: K011286
- Applicant / Sponsor: Ningbo Yujiang Plastic & Rubber Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-05-16
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.