Clearance Summary
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance under submission number K192241, sponsored by O&M Haylard, 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 2020-03-13.
- Submission: K192241
- Applicant / Sponsor: O&M Haylard, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-03-13
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.