Clearance Summary
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance under submission number K033777, sponsored by Syntex Healthcare Products 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 2004-02-05.
- Submission: K033777
- Applicant / Sponsor: Syntex Healthcare Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2004-02-05
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.