K232252
- 510(k) 号
- K232252
- 器械名称
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
- 申请人
- Dehai (Shandong) Medical Gloves, Co., Ltd. CN
- 产品代码
- LZA — Polymer Patient Examination Glove
- 批准日期
- 2023-11-28
- 受理日期
- 2023-07-28
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General Hospital
FDA 官方记录: K232252
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。