Clearance Summary
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES received FDA 510(k) clearance under submission number K061078, sponsored by Bright Element 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 2006-05-19.
- Submission: K061078
- Applicant / Sponsor: Bright Element Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2006-05-19
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.