FDA 510(k)

新福无粉黄色聚氯乙烯病人检查手套

K号: K152719 · 2016-03-01

决定日期2016-03-01

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

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Xinfu Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K152719. 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 Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves?

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Xinfu Medical Products Co., Ltd.. The 510(k) number is K152719.

When did Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2016-03-01, under 510(k) number K152719.

Who is the listed applicant for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Xinfu Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves?

The FDA product code for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves is LYZ.

官方来源

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新福无粉黄色聚氯乙烯病人检查手套

器械摘要

常见问题

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