FDA 510(k)

无粉乳胶检查手套（蓝色），经测试可用于化疗药物和芬太尼柠檬酸盐（XS,S,M,L,XL,XXL）

K号: K241970 · 2024-08-02

申请人Kanglongda Vietnam Protection Technology Company Limited

决定日期2024-08-02

产品代码LZA

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is the device name listed in this FDA 510(k) record. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241970. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. The 510(k) number is K241970.

When did Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241970.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

The FDA 510(k) record lists Kanglongda Vietnam Protection Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is LZA.

列明Kanglongda Vietnam Protection Technology Company Limited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。

K253824无尘乳胶检查手套非无菌黑色 K202356无粉尼龙检查手套（蓝色，紫蓝色，白色，钴蓝色）

相关器械（代码：LZA）

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。

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官方来源

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