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FDA 510(k)

非无菌无粉乳胶检查手套，双色（白色-绿色），用于化疗药物、芬太尼盐酸盐、盐酸氯丙嗪和模拟胃酸；非无菌无粉乳胶检查手套，双色（白色-蓝色），用于化疗药物、芬太尼盐酸盐、盐酸氯丙嗪和模拟胃酸

K号: K252549 · 2026-01-13

申请人Kossan International Sdn Bhd
决定日期2026-01-13
产品代码LZA
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

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 is the device name listed in this FDA 510(k) record. The listed applicant is Kossan International Sdn Bhd. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K252549. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Kossan International Sdn Bhd. The 510(k) number is K252549.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2026-01-13, under 510(k) number K252549.

Who is the listed applicant for 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?

FDA 510(k)记录显示Kossan International Sdn Bhd为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for 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?

The FDA product code for 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 is LZA.

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关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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列明Kossan International Sdn Bhd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260794非无菌无粉乳胶患者检查手套，含有甘草根提取物和尿素，经测试可用于化疗药物、芬太尼柠檬酸盐、盐酸氯丙嗪和胃酸。海洋色K232461无粉乳胶检查手套，粉色，非灭菌，经测试可用于化疗药物和芬太尼柠檬酸盐；无粉乳胶检查手套，橙色，非灭菌，经测试可用于化疗药物和芬太尼柠檬酸盐；无粉乳胶检查手套，蓝色，非灭菌，低皮炎潜力，经测试可用于化疗药物和芬太尼柠檬酸盐；无粉乳胶检查手套，黑色，非灭菌，低皮炎K230573无菌无粉乳胶病人检查手套，黑色，非灭菌，蛋白质含量标签声明（每只手套含有50ug或更少的总可提取物蛋白质）K191800无菌粉无乳胶检查手套，蓝色，非致热原标签声明，无菌粉无乳胶检查手套，白色，非致热原标签声明K190606无粉乳胶患者检查手套，黑色着色，非无菌K183287无粉乳胶患者检查手套，蓝色着色，非无菌，用于化疗药物和芬太尼柠檬酸盐测试；无粉乳胶患者检查手套，白色着色，非无菌，用于化疗药物和芬太尼柠檬酸盐测试；无粉乳胶患者检查手套，黑色着色，非无菌，用于化疗药物和芬太尼柠檬酸盐测试

查看所有 12 个设备 →

相关器械（代码：LZA）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261793无粉乳胶检查手套，适用于化疗药物和芬太尼盐酸盐（蓝色和黑色）使用测试Maxter Healthcare, Inc.K262542可生物降解的尼龙粉末免洗检查手套，绿色；可生物降解的尼龙粉末免洗检查手套，紫蓝色；经测试可用于32种化疗药物、芬太尼和胃酸渗透阻力声明Top Glove Sdn. Bhd.K260312氰化物粉末免费检查手套，蓝色；经测试可用于32种化疗药物和芬太尼渗透阻力；氰化物粉末免费检查手套，紫蓝色；经测试可用于32种化疗药物、盐酸氯丙嗪、芬太尼和胃酸Gmp Medicare Sdn. Bhd.K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用CardinalhealthK260794非无菌无粉乳胶患者检查手套，含有甘草根提取物和尿素，经测试可用于化疗药物、芬太尼柠檬酸盐、盐酸氯丙嗪和胃酸。海洋色Kossan International Sdn BhdK262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套O&M Halyard, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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