Clearance Summary
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- received FDA 510(k) clearance under submission number K101596, sponsored by Kimberly-Clark. 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 2010-07-21.
- Submission: K101596
- Applicant / Sponsor: Kimberly-Clark
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2010-07-21
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.