FDA 510(k)

一次性无粉聚氯乙烯检查手套，黑色/蓝色/紫色

K号: K220992 · 2022-10-19

申请人Ever Global (Vietnam) Enterprise Corporation

决定日期2022-10-19

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, Black/Blue/Purple is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K220992. 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, Black/Blue/Purple?

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K220992.

When did Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple received FDA 510(k) clearance on 2022-10-19, under 510(k) number K220992.

Who is the listed applicant for Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corporation 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, Black/Blue/Purple?

The FDA product code for Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is LYZ.

列明Ever Global (Vietnam) Enterprise 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。

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官方来源

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