Clearance Summary
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) received FDA 510(k) clearance under submission number K081027, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-06-30.
- Submission: K081027
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2008-06-30
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.