K250313

Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

510(k) 号: K250313
器械名称: Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
申请人: Harps Europe Manufacturing GmbH AT
产品代码: KGO — Surgeon'S Gloves
批准日期: 2025-08-19
受理日期: 2025-02-03
决定: Substantially Equivalent
审查途径: Abbreviated
咨询委员会: General, Plastic Surgery

也可从 FDA 官方下载： K250313.pdf

FDA 官方记录： K250313

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。