Clearance Summary
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE received FDA 510(k) clearance under submission number K003563, sponsored by Ning BO Yujiang Rubber & Plastic Co.. 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 2001-01-02.
- Submission: K003563
- Applicant / Sponsor: Ning BO Yujiang Rubber & Plastic Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-01-02
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.