FDA 510(k)

手术隔离服

K号: K212357 · 2022-01-20

申请人Wuhan Zonsen Medical Products Co., Ltd.

决定日期2022-01-20

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

Surgical isolation gown is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212357. 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 Surgical isolation gown?

Surgical isolation gown is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K212357.

When did Surgical isolation gown receive FDA 510(k) clearance?

Surgical isolation gown received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212357.

Who is the listed applicant for Surgical isolation gown?

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

What is the FDA product code for Surgical isolation gown?

The FDA product code for Surgical isolation gown is FYC.

列明Wuhan Zonsen Medical Products 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。

K223600灭菌包装 K213601外科口罩 K213688丙烯酸丁腈检查手套（型号：ZMG1351）K212861外科手术服，加固外科手术服 K202191外科口罩

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

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