K240930

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue

510(k) 号: K240930
器械名称: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
申请人: Sri Trang Gloves Thailand (Public Company Limited) TH
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2024-07-02
受理日期: 2024-04-04
决定: Substantially Equivalent
审查途径: Abbreviated
咨询委员会: General Hospital

该申请提交的是 510(k) Statement 而非 Summary，FDA 不公开摘要全文；可向申请人索取。

FDA 官方记录： K240930

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。