K251716

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

510(k) 号: K251716
器械名称: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
申请人: Basic Medical Technology, Inc. CA · US
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2025-08-27
受理日期: 2025-06-04
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 · 1.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K251716.pdf

FDA 官方记录： K251716

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。