FDA 510(k)

医用口罩（型号：KKF-1A）

K号: K202316 · 2021-03-03

申请人Han Zhaoqing Sporting Goods Company Limited

决定日期2021-03-03

产品代码FXX

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决定实质等同

器械摘要

Medical mask (Model: KKF-1A) is the device name listed in this FDA 510(k) record. The listed applicant is Han Zhaoqing Sporting Goods Company Limited. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K202316. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medical mask (Model: KKF-1A)?

Medical mask (Model: KKF-1A) is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Han Zhaoqing Sporting Goods Company Limited. The 510(k) number is K202316.

When did Medical mask (Model: KKF-1A) receive FDA 510(k) clearance?

Medical mask (Model: KKF-1A) received FDA 510(k) clearance on 2021-03-03, under 510(k) number K202316.

Who is the listed applicant for Medical mask (Model: KKF-1A)?

The FDA 510(k) record lists Han Zhaoqing Sporting Goods Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical mask (Model: KKF-1A)?

The FDA product code for Medical mask (Model: KKF-1A) is FXX.

列明Han Zhaoqing Sporting Goods Company Limited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。

K202314手术面罩（型号：KKF-2A）

相关器械（代码：FXX）

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。

K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.

官方来源

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