FDA 510(k)

丙烯酸丁腈检查手套，无粉，蓝色

K号: K211699 · 2021-08-20

申请人Hengchang (Dongying) Medical Technology Co., Ltd.

决定日期2021-08-20

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 Exam Gloves, Powder Free, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K211699. 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 Exam Gloves, Powder Free, Blue?

Nitrile Exam Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211699.

When did Nitrile Exam Gloves, Powder Free, Blue receive FDA 510(k) clearance?

Nitrile Exam Gloves, Powder Free, Blue received FDA 510(k) clearance on 2021-08-20, under 510(k) number K211699.

Who is the listed applicant for Nitrile Exam Gloves, Powder Free, Blue?

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

What is the FDA product code for Nitrile Exam Gloves, Powder Free, Blue?

The FDA product code for Nitrile Exam Gloves, Powder Free, Blue is LZA.

列明Hengchang (Dongying) Medical Technology 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。

K211714丙烯酸丁腈检查手套，无粉，蓝色（用于化疗测试）

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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