K232614

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

510(k) 号: K232614
器械名称: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet 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: 2024-05-13
受理日期: 2023-08-28
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： K232614

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。