Clearance Summary
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE received FDA 510(k) clearance under submission number K955918, sponsored by Sinochem Ningbo Imp & Exp Corp.. 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 1996-06-27.
- Submission: K955918
- Applicant / Sponsor: Sinochem Ningbo Imp & Exp Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1996-06-27
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.