K254285

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue

510(k) 号: K254285
器械名称: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
申请人: Hartalega NGC Sdn. Bhd. MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2026-07-20
受理日期: 2025-12-31
决定: Substantially Equivalent
审查途径: Special
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 2.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K254285.pdf

FDA 官方记录： K254285

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。