Clearance Summary
Fusion Black Powder-Free Nitrile Exam Glove received FDA 510(k) clearance under submission number K150113, sponsored by Halyard Health. 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 2015-06-18.
- Submission: K150113
- Applicant / Sponsor: Halyard Health
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2015-06-18
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.