Clearance Summary
GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] received FDA 510(k) clearance under submission number K243796, sponsored by Glove One, LLC. 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 2025-06-03.
- Submission: K243796
- Applicant / Sponsor: Glove One, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2025-06-03
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.