FDA 510(k)

无菌无粉乳胶检查手套，蛋白质含量标签声明为50ug/dm2或以下

K号: K162175 · 2016-11-21

决定日期2016-11-21

产品代码LYY

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 Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K162175. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Vietglove Corporation. The 510(k) number is K162175.

When did Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less receive FDA 510(k) clearance?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162175.

Who is the listed applicant for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is LYY.

列明Vietglove Corporation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。

K201428Powder Free Black Nitrile Examination Glove K170094无粉乳胶检查手套，聚合物涂层 K153562无菌无粉蓝色丁腈检查手套

相关器械（代码：LYY）

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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