FDA 510(k)

Clear乙烯基粉末自由患者检查手套

K号: K171317 · 2017-09-11

申请人Shandong Zhi Hong Medical Products, Co. , Ltd.

决定日期2017-09-11

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

Clear Vinyl Powder-free Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhi Hong Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K171317. 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 Clear Vinyl Powder-free Patient Examination Gloves?

Clear Vinyl Powder-free Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Shandong Zhi Hong Medical Products, Co. , Ltd.. The 510(k) number is K171317.

When did Clear Vinyl Powder-free Patient Examination Gloves receive FDA 510(k) clearance?

Clear Vinyl Powder-free Patient Examination Gloves received FDA 510(k) clearance on 2017-09-11, under 510(k) number K171317.

Who is the listed applicant for Clear Vinyl Powder-free Patient Examination Gloves?

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

What is the FDA product code for Clear Vinyl Powder-free Patient Examination Gloves?

The FDA product code for Clear Vinyl Powder-free Patient Examination Gloves is LYZ.

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Clear乙烯基粉末自由患者检查手套

器械摘要

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