FDA 510(k)

无粉白色，绿色灭菌多氯丙烯共聚物手术手套 - 经化疗药物使用测试

K号: K180221 · 2018-08-08

决定日期2018-08-08

产品代码KGO

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决定实质等同

器械摘要

Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corporation Sdn. Bhd.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180221. 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 Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs?

Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Smart Glove Corporation Sdn. Bhd.. The 510(k) number is K180221.

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

Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180221.

Who is the listed applicant for Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs?

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

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

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

列明Smart Glove Corporation 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。

K213373无粉绿色生物降解尼龙检查手套，经化疗药物和芬太尼柠檬酸盐使用测试 K183280无粉白色蓝色灭菌乳胶共聚物检查手套，用于化疗药物测试 K181047无粉白色，蓝色灭菌尼龙共聚物手术手套-经化疗药物使用测试 K171743无粉粉色聚氯乙烯共聚物检查手套，无粉黑色聚氯乙烯共聚物检查手套

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

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