FDA 510(k)

医用PVC检查手套

K号: K210821 · 2021-07-09

申请人Jiangxi Hongda Medical Equipment Group , Ltd.

决定日期2021-07-09

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

Medical PVC Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K210821. 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 Medical PVC Examination Gloves?

Medical PVC Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210821.

When did Medical PVC Examination Gloves receive FDA 510(k) clearance?

Medical PVC Examination Gloves received FDA 510(k) clearance on 2021-07-09, under 510(k) number K210821.

Who is the listed applicant for Medical PVC Examination Gloves?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical PVC Examination Gloves?

The FDA product code for Medical PVC Examination Gloves is LYZ.

列明Jiangxi Hongda Medical Equipment Group , 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。

K211753无菌安全注射器 K210578医用乳胶检查手套（免洗手，蓝色）K163160无菌一次性使用输液器 K163162无菌一次性使用安全注射器 K163161无菌一次性使用注射器及针头

官方来源

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