Clearance Summary
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE received FDA 510(k) clearance under submission number K083156, sponsored by Giga-Drive Sdn, Bhd. 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 2009-05-08.
- Submission: K083156
- Applicant / Sponsor: Giga-Drive Sdn, Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-05-08
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.