FDA 510(k)

一次性医用口罩

K号: K252650 · 2026-01-05

决定日期2026-01-05

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 Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Makrite Industries, Inc.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) number K252650. 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 Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2026-01-05. The listed applicant is Makrite Industries, Inc.. The 510(k) number is K252650.

When did Disposable Medical Face Mask receive FDA 510(k) clearance?

Disposable Medical Face Mask received FDA 510(k) clearance on 2026-01-05, under 510(k) number K252650.

Who is the listed applicant for Disposable Medical Face Mask?

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

What is the FDA product code for Disposable Medical Face Mask?

The FDA product code for Disposable Medical Face Mask is FXX.

列明Makrite Industries, 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。

K240258一次性医用口罩 (M643BE)K220550一次性外科口罩（M663BE，M663BT）

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.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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。