K260867
- 510(k) 号
- K260867
- 器械名称
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
- 申请人
- Hartalega NGC Sdn. Bhd. MY
- 产品代码
- LZA — Polymer Patient Examination Glove
- 批准日期
- 2026-06-17
- 受理日期
- 2026-03-17
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- General Hospital
FDA 官方记录: K260867
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。