K250861

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

510(k) 号: K250861
器械名称: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
申请人: Hartalega NGC Sdn. Bhd. MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-10-23
受理日期: 2025-03-21
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 2.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K250861.pdf

FDA 官方记录： K250861

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。