K232079

Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

510(k) 号
K232079
器械名称
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
申请人
Wrp Asia Pacific Sdn. Bhd. MY
产品代码
KGO — Surgeon'S Gloves
批准日期
2024-03-28
受理日期
2023-07-13
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
General, Plastic Surgery
PDF下载 510(k) Summary本站存档 · 1.1 MB · FDA 公有领域文件

也可从 FDA 官方下载: K232079.pdf

FDA 官方记录: K232079
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。