FDA 510(k)

Glide-On 聚氯乙烯检查手套

K号: K151754 · 2016-03-22

决定日期2016-03-22

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

Glide-On Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K151754. 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 Glide-On Vinyl Examination Gloves?

Glide-On Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Medline Industries, Inc.. The 510(k) number is K151754.

When did Glide-On Vinyl Examination Gloves receive FDA 510(k) clearance?

Glide-On Vinyl Examination Gloves received FDA 510(k) clearance on 2016-03-22, under 510(k) number K151754.

Who is the listed applicant for Glide-On Vinyl Examination Gloves?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glide-On Vinyl Examination Gloves?

The FDA product code for Glide-On Vinyl Examination Gloves is LYZ.

列明Medline Industries, Inc.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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