K260867

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

510(k) 号
K260867
器械名称
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
申请人
Hartalega NGC Sdn. Bhd. MY
产品代码
LZA — Polymer Patient Examination Glove
批准日期
2026-06-17
受理日期
2026-03-17
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 · 2.8 MB · FDA 公有领域文件

也可从 FDA 官方下载: K260867.pdf

FDA 官方记录: K260867
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。