FDA 510(k)

Level 2标准手术服，Level 3标准手术服，Level 3加固手术服

K号: K211422 · 2021-07-02

申请人Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

决定日期2021-07-02

产品代码FYA

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决定实质等同

器械摘要

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K211422. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. The 510(k) number is K211422.

When did Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown receive FDA 510(k) clearance?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown received FDA 510(k) clearance on 2021-07-02, under 510(k) number K211422.

Who is the listed applicant for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

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

What is the FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

The FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is FYA.

列明Jiangsu Medplus Non-Woven Manufacturer 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。

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相关器械（代码：FYA）

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。

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官方来源

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