FDA 510(k)

无菌粉无乳胶手术手套，用于化疗药物测试

K号: K232444 · 2023-12-20

申请人Grand Work Plastic Products Co., Ltd.

决定日期2023-12-20

产品代码KGO

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决定实质等同

器械摘要

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232444. 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 Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K232444.

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

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232444.

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

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Grand Work Plastic Products Co., Ltd.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。

K232039无菌粉无乳胶检查手套（蓝色），用于化疗药物测试和芬太尼盐酸盐 K230217无菌聚异丁烯粉无手术手套，用于化疗药物测试 K222892无粉聚氨酯检查手套，蓝色，经过与化疗药物使用的测试 K213574丁腈/氯丁橡胶混合无粉检查手套（黑色）K220249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）K220250无菌粉无乳胶检查手套（蓝色），用于化疗药物测试

查看所有 8 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.K231902GAMMEX PI 混合微 (340002055)；GAMMEX PI 混合微 (340002060)；GAMMEX PI 混合微 (340002065)；GAMMEX PI 混合微 (340002070)；GAMMEX PI 混合微 (340002075)；GAMMEX PI 混合微 (340002080)；GAMMEX PI 混合微 (340002085)；GAMMEX PI 混合微 (340002090)Ansell Healthcare

官方来源

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