FDA 510(k) 实质等同认定·· 2026-07-28AI 评分51
FDA 510(k) 实质等同认定：Hartalega 化疗药物测试外科手套（K260558）
510(k) 实质等同认定：Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate（K260558）
AI 导读
FDA 对 Hartalega NGC Sdn. Bhd. 的 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 及含 Colloidal Oatmeal 版本作出 510(k) 实质等同认定（SESE）。
来源：FDA 510(k) 实质等同认定 · accessdata.fda.gov