K243796

GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

510(k) number: K243796
Device name: GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Applicant: Glove One, LLC NC · US
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2025-06-03
Date received: 2024-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

Also available from FDA: K243796.pdf

Official FDA record: K243796

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.