K243796

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

510(k) 号: K243796
器械名称: GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
申请人: Glove One, LLC NC · US
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-06-03
受理日期: 2024-12-10
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

也可从 FDA 官方下载： K243796.pdf

FDA 官方记录： K243796

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。