K251319

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

510(k) 号: K251319
器械名称: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff
申请人: Hartalega NGC Sdn. Bhd. MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-07-30
受理日期: 2025-04-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 1.0 MB · FDA 公有领域文件

也可从 FDA 官方下载： K251319.pdf

FDA 官方记录： K251319

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。