Clearance Summary
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove received FDA 510(k) clearance under submission number K200633, sponsored by 0 & M Halyard, Inc.. 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 2020-10-11.
- Submission: K200633
- Applicant / Sponsor: 0 & M Halyard, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-10-11
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.