FDA 510(k)

乙烯/丁腈混合检查手套

K号: K213634 · 2022-02-18

申请人Dezhou Hengchang Medical Technology Co., Ltd.

决定日期2022-02-18

产品代码LYZ

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

Vinyl/Nitrile Blend Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213634. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vinyl/Nitrile Blend Exam Glove?

Vinyl/Nitrile Blend Exam Glove is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. The 510(k) number is K213634.

When did Vinyl/Nitrile Blend Exam Glove receive FDA 510(k) clearance?

Vinyl/Nitrile Blend Exam Glove received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213634.

Who is the listed applicant for Vinyl/Nitrile Blend Exam Glove?

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

What is the FDA product code for Vinyl/Nitrile Blend Exam Glove?

The FDA product code for Vinyl/Nitrile Blend Exam Glove is LYZ.

列明Dezhou Hengchang 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。

K220055一次性，乙烯基检查手套，黄色 K213625乙烯基检查手套

官方来源

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