K232064

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

510(k) 号: K232064
器械名称: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
申请人: Isikel Manufacturing, LLC TX · US
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2023-10-02
受理日期: 2023-07-11
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

也可从 FDA 官方下载： K232064.pdf

FDA 官方记录： K232064

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。