FDA 510(k)

一次性无粉聚氯乙烯检查手套，透明/黄色

K号: K170575 · 2017-05-16

申请人Ever Global (Vietnam) Enterprise Corp

决定日期2017-05-16

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

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corp. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170575. 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 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ever Global (Vietnam) Enterprise Corp. The 510(k) number is K170575.

When did Disposable Powder Free Vinyl Exam Glove, Clear/Yellow receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170575.

Who is the listed applicant for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

The FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is LYZ.

列明Ever Global (Vietnam) Enterprise Corp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。

K193555一次性无粉乳胶检查手套，蓝色，经化疗药物和芬太尼盐酸盐使用测试 K171422一次性无粉乳胶检查手套，白色/蓝色/黑色/粉色

官方来源

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