Clearance Summary
Cardinal Health Nitrile Exam Gloves received FDA 510(k) clearance under submission number K241780, sponsored by Cardinal Health200, LLC. 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 2024-08-23.
- Submission: K241780
- Applicant / Sponsor: Cardinal Health200, LLC
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2024-08-23
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.