FDA 510(k)

HG PRO XP 氮化橡胶无粉检查手套，用于化疗药物测试

K号: K162381 · 2017-01-31

决定日期2017-01-31

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

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Healthy Glove Co., Ltd.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K162381. 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 HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Healthy Glove Co., Ltd.. The 510(k) number is K162381.

When did HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-01-31, under 510(k) number K162381.

Who is the listed applicant for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Healthy Glove Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs is LZA.

列明Healthy Glove 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。

K152479HG Pro 氮化橡胶无粉检查手套

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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