FDA 510(k)

一次性医用聚（氯乙烯）检查手套（透明，无色）

K号: K182043 · 2018-09-21

申请人Hebei Titans Hongsen Medical Technology Co., Ltd.

决定日期2018-09-21

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

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K182043. 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 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When did Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182043.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

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

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is LYZ.

列明Hebei Titans Hongsen Medical Technology 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。

K240361无菌无粉绿色丁腈检查手套（XS/S/M/L/XL）；无菌无粉粉色丁腈检查手套（XS/S/M/L/XL）；无菌无粉紫色丁腈检查手套（XS/S/M/L/XL）K223895一次性医用检查丁腈手套 K221374一次性医用橡胶检查手套（XS/S/M/L/XL）K212097一次性医用外科口罩 K211229聚氯乙烯复合检查手套 K181130无菌无粉蓝色丁腈检查手套，经测试可用于化疗药物

查看所有 7 个设备 →

官方来源

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