Clearance Summary
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) received FDA 510(k) clearance under submission number K061551, sponsored by Medipure Corporation (M) 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 2006-08-24.
- Submission: K061551
- Applicant / Sponsor: Medipure Corporation (M) Sdn. Bhd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2006-08-24
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.