FDA 510(k)

外科隔离手术服

K号: K220528 · 2022-06-10

决定日期2022-06-10

产品代码FYC

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决定实质等同

器械摘要

Surgical Isolation Cover Gown is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Dymex Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220528. 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 Cover Gown?

Surgical Isolation Cover Gown is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Wuhan Dymex Healthcare Co., Ltd.. The 510(k) number is K220528.

When did Surgical Isolation Cover Gown receive FDA 510(k) clearance?

Surgical Isolation Cover Gown received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220528.

Who is the listed applicant for Surgical Isolation Cover Gown?

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

What is the FDA product code for Surgical Isolation Cover Gown?

The FDA product code for Surgical Isolation Cover Gown is FYC.

列明Wuhan Dymex Healthcare 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。

K211809外科手术服 K210433Surgical Face Mask (耳挂式和系带式)K182515Surgical Face Mask

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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