FDA 510(k)

聚氯乙烯复合检查手套

K号: K211229 · 2021-07-29

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

决定日期2021-07-29

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

Vinyl compound examination gloves 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 2021-07-29 under 510(k) number K211229. 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 Vinyl compound examination gloves?

Vinyl compound examination gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K211229.

When did Vinyl compound examination gloves receive FDA 510(k) clearance?

Vinyl compound examination gloves received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211229.

Who is the listed applicant for Vinyl compound examination gloves?

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 Vinyl compound examination gloves?

The FDA product code for Vinyl compound examination gloves 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 K182043一次性医用聚（氯乙烯）检查手套（透明，无色）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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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。