FDA 510(k)

Plus Medical 三级隔离服

K号: K212698 · 2022-03-02

决定日期2022-03-02

产品代码FYC

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Plus Medical Isolation Gown Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K212698. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plus Medical Isolation Gown Level 3?

Plus Medical Isolation Gown Level 3 is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K212698.

When did Plus Medical Isolation Gown Level 3 receive FDA 510(k) clearance?

Plus Medical Isolation Gown Level 3 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212698.

Who is the listed applicant for Plus Medical Isolation Gown Level 3?

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

What is the FDA product code for Plus Medical Isolation Gown Level 3?

The FDA product code for Plus Medical Isolation Gown Level 3 is FYC.

列明Foshan Nanhai Plus Medical 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。

K222480标准外科服（AAMI Level 2）；加固外科服（AAMI Level 2）K213177Plus Medical 防护服 K211036Plus Medical 化疗病袍 K212610Surgical Face Mask K210143标准外科服（AAMI Level 3），加固外科服（AAMI Level 3）

相关器械（代码：FYC）

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。

K232849Halyard Tri-Layer AAMI 3隔离服，L，蓝色（54310），Halyard Tri-Layer AAMI 3隔离服，超大号，蓝色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化疗隔离服Copioumed International, Inc.K223467一次性隔离服Nanning Tecbod Biological Technology Co., Ltd.K223304一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Technology Co., Ltd.K223411一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等级3隔离服Paneffort, LLC

官方来源

在 FDA 数据库中查看 →

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。