K252244
- 510(k) 号
- K252244
- 器械名称
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
- 申请人
- Ever Global (Vietnam) Enterprise Corporation VN
- 产品代码
- LZA — Polymer Patient Examination Glove
- 批准日期
- 2025-08-21
- 受理日期
- 2025-07-18
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- General Hospital
FDA 官方记录: K252244
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。