K243818

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

510(k) 号: K243818
器械名称: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
申请人: Hartalega NGC Sdn. Bhd. MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-01-08
受理日期: 2024-12-12
决定: Substantially Equivalent
审查途径: Special
咨询委员会: General Hospital

也可从 FDA 官方下载： K243818.pdf

FDA 官方记录： K243818

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。