Clearance Summary
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs received FDA 510(k) clearance under submission number K182096, sponsored by Owens & Minor 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 2018-11-02.
- Submission: K182096
- Applicant / Sponsor: Owens & Minor Halyard, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2018-11-02
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.