Clearance Summary
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL received FDA 510(k) clearance under submission number K023153, sponsored by Ansell Healthcare Products, Inc.. 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 2002-11-13.
- Submission: K023153
- Applicant / Sponsor: Ansell Healthcare Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2002-11-13
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.