FDA 510(k)

Protect X 级别3隔离服

K号: K211538 · 2021-11-17

决定日期2021-11-17

产品代码FYC

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决定实质等同

器械摘要

Protect X Level 3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Azac Group. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K211538. 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 Protect X Level 3 Isolation Gown?

Protect X Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Azac Group. The 510(k) number is K211538.

When did Protect X Level 3 Isolation Gown receive FDA 510(k) clearance?

Protect X Level 3 Isolation Gown received FDA 510(k) clearance on 2021-11-17, under 510(k) number K211538.

Who is the listed applicant for Protect X Level 3 Isolation Gown?

The FDA 510(k) record lists Azac Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protect X Level 3 Isolation Gown?

The FDA product code for Protect X Level 3 Isolation Gown is FYC.

列明Azac Group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。

K242689AAMI 级别 4 保护服；外衣

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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