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FDA 510(k)

一次性手术口罩（非无菌）(EFX3PLBLKMSK300)

K号: K253398 · 2026-02-19

申请人Efofex, Inc.
决定日期2026-02-19
产品代码FXX
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is the device name listed in this FDA 510(k) record. The listed applicant is Efofex, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K253398. 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 Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Efofex, Inc.. The 510(k) number is K253398.

When did Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) receive FDA 510(k) clearance?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253398.

Who is the listed applicant for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

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

What is the FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

The FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is FXX.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Efofex, Inc.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。

K223823一次性外科口罩

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.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.K252941HALYARD* 成人面部口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带O&M Halyard, Inc.

官方来源

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