K252549

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

510(k) 号: K252549
器械名称: Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
申请人: Kossan International Sdn Bhd MY
产品代码: LZA — Polymer Patient Examination Glove
批准日期: 2026-01-13
受理日期: 2025-08-13
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

该申请提交的是 510(k) Statement 而非 Summary，FDA 不公开摘要全文；可向申请人索取。

FDA 官方记录： K252549

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。