FDA 510(k)

Cardinal Health聚氯乙烯无粉检查手套，带Neu-thera涂层

K号: K160411 · 2016-07-25

决定日期2016-07-25

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

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K160411. 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 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K160411.

When did Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating receive FDA 510(k) clearance?

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160411.

Who is the listed applicant for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

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

What is the FDA product code for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

The FDA product code for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is LYZ.

列明Cardinal Health, 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。

K170198Cardinal Health无菌聚异丁烯混合物无粉手术手套，适用于化疗药物（白色）K160875Cardinal Health无菌聚异丁烯无粉骨科手术手套，带水凝胶涂层 K153316Cardinal Health无菌氯丁橡胶涂层无粉手术手套，适用于化疗药物（黄色）

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。