Clearance Summary
HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves received FDA 510(k) clearance under submission number K160709, 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 2016-09-06.
- Submission: K160709
- Applicant / Sponsor: Halyard Health
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2016-09-06
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.