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FDA 510(k)

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）

K号: K230573 · 2023-06-13

申请人Kossan International Sdn Bhd
决定日期2023-06-13
产品代码LYY
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

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) 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 2023-06-13 under 510(k) number K230573. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Kossan International Sdn Bhd. The 510(k) number is K230573.

When did Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) receive FDA 510(k) clearance?

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) received FDA 510(k) clearance on 2023-06-13, under 510(k) number K230573.

Who is the listed applicant for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

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 Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

The FDA product code for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) is LYY.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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K252549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：LYY）

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。

K250069无菌无粉天然橡胶乳胶检查手套 - 蓝色，非灭菌，蛋白质含量声明为每dm2 50微克或以下蛋白质Comfort Rubber Gloves Industries Sdn. Bhd.K240266天然乳胶检查手套（海洋蓝和自然白）Sri Trang Gloves (Thailand) Public Company LimitedK223298无菌乳胶检查手套，无粉（S，M，L，超L）Shandong Intco Medical Products Co, Ltd.K222612无粉乳胶检查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K221667非无菌无粉乳胶检查手套New Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

官方来源

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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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