Clearance Summary
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES received FDA 510(k) clearance under submission number K083337, sponsored by Terang Nusa Sdn Bhd. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-01-27.
- Submission: K083337
- Applicant / Sponsor: Terang Nusa Sdn Bhd
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2009-01-27
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.