Clearance Summary
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) received FDA 510(k) clearance under submission number K100895, sponsored by Dipped Products Limited. 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 2011-05-27.
- Submission: K100895
- Applicant / Sponsor: Dipped Products Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2011-05-27
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.