K231365
- 510(k) 号
- K231365
- 器械名称
- Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
- 申请人
- Anhui Intco Medical Products Co., Ltd. CN
- 产品代码
- LZA — Polymer Patient Examination Glove
- 批准日期
- 2024-03-01
- 受理日期
- 2023-05-11
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General Hospital
FDA 官方记录: K231365
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。