FDA 510(k)

聚氯乙烯无粉无菌手术手套，白色，用于化疗药物测试

K号: K182176 · 2019-03-28

决定日期2019-03-28

产品代码KGO

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决定实质等同

器械摘要

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2019-03-28 under 510(k) number K182176. 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 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-28. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K182176.

When did Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-28, under 510(k) number K182176.

Who is the listed applicant for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Pt. Medisafe Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs?

The FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs is KGO.

列明Pt. Medisafe Technologies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。

K201774聚氯乙烯无粉无菌手术手套，低皮炎潜力，用于化疗药物测试 K173258聚氯乙烯无粉无菌手术手套，白色，用于化疗药物测试 K163041无粉聚氯乙烯检查手套-粉色含芦荟和维生素E

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.

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