FDA 510(k)

AAMI3 隔离服

K号: K213832 · 2022-05-16

决定日期2022-05-16

产品代码FYC

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决定实质等同

器械摘要

AAMI3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K213832. 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 AAMI3 Isolation Gown?

AAMI3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K213832.

When did AAMI3 Isolation Gown receive FDA 510(k) clearance?

AAMI3 Isolation Gown received FDA 510(k) clearance on 2022-05-16, under 510(k) number K213832.

Who is the listed applicant for AAMI3 Isolation Gown?

The FDA 510(k) record lists Hubei Xinxin Non-Woven Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AAMI3 Isolation Gown?

The FDA product code for AAMI3 Isolation Gown is FYC.

列明Hubei Xinxin Non-Woven 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。

K253003非无菌三级手术服（4025）；无菌三级手术服（M4025）；非无菌加固四级手术服（G4025）；加固无菌四级手术服（GM4025）K214116AAMI4 隔离服 K212120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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