FDA 510(k)

聚异戊二烯手术手套（统一双层），无菌，经测试可用于与化疗药物和芬太尼一起使用

K号: K230578 · 2023-08-31

决定日期2023-08-31

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 Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K230578. 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 Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl?

Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K230578.

When did Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2023-08-31, under 510(k) number K230578.

Who is the listed applicant for Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl?

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

What is the FDA product code for Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA product code for Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl is KGO.

列明Wrp Asia Pacific 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。

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 K232538双色乳胶检查手套，无粉，非无菌，用于化疗药物和芬太尼测试 K222058聚异戊二烯手术手套，无粉，无菌，经测试可用于与化疗药物和芬太尼耐药性 K211601无菌无粉乳胶检查手套 K210330Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant K203030无粉丁腈手术手套，无菌，适用于化疗药物测试

查看所有 10 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。