FDA 510(k)

丙烯酸丁腈检查手套

K号: K213739 · 2022-06-22

决定日期2022-06-22

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

Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Runheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K213739. 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 Nitrile Examination Gloves?

Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Hangzhou Runheng Medical Co., Ltd.. The 510(k) number is K213739.

When did Nitrile Examination Gloves receive FDA 510(k) clearance?

Nitrile Examination Gloves received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213739.

Who is the listed applicant for Nitrile Examination Gloves?

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

What is the FDA product code for Nitrile Examination Gloves?

The FDA product code for Nitrile Examination Gloves is LZA.

列明Hangzhou Runheng Medical 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。

K213736医疗口罩

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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