K250342

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

510(k) 号: K250342
器械名称: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
申请人: Encompass Industries Sdn. Bhd. MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-07-08
受理日期: 2025-02-06
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

也可从 FDA 官方下载： K250342.pdf

FDA 官方记录： K250342

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。