K232079
- 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
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。