FDA 510(k)

Surgical Face Mask (HNFM0103)

K号: K221838 · 2022-08-17

决定日期2022-08-17

产品代码FXX

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决定实质等同

器械摘要

Surgical Face Mask (HNFM0103) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hua EN Industrial Co, Ltd.. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K221838. 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 Surgical Face Mask (HNFM0103)?

Surgical Face Mask (HNFM0103) is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Shanghai Hua EN Industrial Co, Ltd.. The 510(k) number is K221838.

When did Surgical Face Mask (HNFM0103) receive FDA 510(k) clearance?

Surgical Face Mask (HNFM0103) received FDA 510(k) clearance on 2022-08-17, under 510(k) number K221838.

Who is the listed applicant for Surgical Face Mask (HNFM0103)?

The FDA 510(k) record lists Shanghai Hua EN Industrial Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask (HNFM0103)?

The FDA product code for Surgical Face Mask (HNFM0103) is FXX.

列明Shanghai Hua EN Industrial 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。

K221222Surgical Face Mask (HNFM0304)

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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