FDA 510(k)

Gammex® PI Plus手套内手套系统，用于化疗药物

K号: K213289 · 2023-05-26

决定日期2023-05-26

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

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K213289. 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 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K213289.

When did Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-26, under 510(k) number K213289.

Who is the listed applicant for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is KGO.

列明Ansell Healthcare Products, LLC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。

K230079经测试可用于与化疗药物和低皮炎潜力一起使用的聚异戊二烯手术手套 K212148非灭菌无粉聚氯乙烯检查手套（蓝色），用于化疗药物 K210401Microflex 硝基患者检查手套蓝色测试用于化疗药物和芬太尼盐酸盐，Microflex 硝基患者检查手套绿色测试用于化疗药物和芬太尼盐酸盐，Microflex 硝基患者检查手套黑色测试用于化疗药物和芬太尼盐酸盐 K200671Microflex 硝基患者检查手套含芦荟和洋甘菊蓝绿粉色测试用于 K190018Gammex非乳胶PI白色聚异丁烯手术手套，用于化疗药物 K182948Gammex PI混合手术手套，用于化疗药物

查看所有 14 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 Limited K250313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 GmbH K240790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。