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FDA 510(k)

用于化疗药物的聚异戊二烯无粉手术手套（蓝色），用于化疗药物的自然色聚异戊二烯无粉手术手套

K号: K200897 · 2020-06-01

申请人Hartalega Sdn Bhd
决定日期2020-06-01
产品代码KGO
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K200897. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K200897.

When did Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) receive FDA 510(k) clearance?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) received FDA 510(k) clearance on 2020-06-01, under 510(k) number K200897.

Who is the listed applicant for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

The FDA 510(k) record lists Hartalega Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

The FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is KGO.

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Hartalega 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。

K201748天然乳胶无粉手术手套，每克手套蛋白质标注50微克或更少，并经过化疗药物使用测试K201531无菌乳胶粉无检查手套，用于化疗药物和芬太尼盐酸盐（蓝色）K180645无菌无粉检查手套，含有USP胶状燕麦和经测试可用于化疗药物 - （柠檬绿色）K180786无菌乳胶粉无检查手套，用于化疗药物测试，水蓝色（ABLU），无菌乳胶粉无检查手套，用于化疗药物测试，紫蓝色（VBLU） - 延长袖K173509可降解乳胶检查手套，无粉，蓝色K180644无粉乳胶手套，含有胶体燕麦 - 柠檬绿

查看所有 17 个设备 →

相关器械（代码：KGO）

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。

K260558无粉乳胶外科手套，适用于化疗药物和芬太尼盐酸盐的使用测试；含胶体燕麦的无粉乳胶外科手套，适用于化疗药物和芬太尼盐酸盐的使用测试Hartalega NGC Sdn. Bhd.K253060无菌乳胶无粉手术手套Protect Gloves Company LimitedK250313无菌无粉合成橡胶外科手套，绿色，经测试可用于化疗药物和胃酸Harps Europe Manufacturing GmbHK240790聚异戊二烯手术手套Suzhou Colour-Way New Material Co., Ltd.K232079天然橡胶乳胶外科手套，无粉，无菌，经化疗药物和芬太尼使用测试（绿色）；天然橡胶乳胶（条状/涂层）/（条状/包装）外科手套，无粉，无菌，经化疗药物和芬太尼使用测试Wrp Asia Pacific Sdn. Bhd.K232444无菌粉无乳胶手术手套，用于化疗药物测试Grand Work Plastic Products Co., Ltd.

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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