FDA 510(k)

一次性无粉聚氯乙烯检查手套，透明/黄色

K号: K172357 · 2017-12-29

决定日期2017-12-29

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 Growth (Vietnam) Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-29 under 510(k) number K172357. 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 2017-12-29. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. The 510(k) number is K172357.

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 2017-12-29, under 510(k) number K172357.

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

The FDA 510(k) record lists Ever Growth (Vietnam) Co. , Ltd. 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 Growth (Vietnam) 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。

K190942一次性无粉乳胶检查手套，粉/黑色 K190860一次性无粉乳胶检查手套，经化疗药物使用测试，白色，一次性无粉乳胶检查手套，经化疗药物使用测试，橙色 K190736一次性无粉乳胶检查手套，蓝色，经化疗药物使用测试

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。