Clearance Summary
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) received FDA 510(k) clearance under submission number K200150, sponsored by Medline Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-10-26.
- Submission: K200150
- Applicant / Sponsor: Medline Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-10-26
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.