Clearance Summary
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance under submission number K180646, 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 2018-06-27.
- Submission: K180646
- Applicant / Sponsor: Halyard Health
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2018-06-27
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.