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K250630

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

510(k) 号
K250630
器械名称
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and 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
2025-05-22
受理日期
2025-03-03
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 · 1.1 MB · FDA 公有领域文件

也可从 FDA 官方下载: K250630.pdf

FDA 官方记录: K250630
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。