FDA 510(k)

HALYARD* 成人面部口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带

K号: K252941 · 2025-12-11

决定日期2025-12-11

产品代码FXX

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决定实质等同

器械摘要

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252941. 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 HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K252941.

When did HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops receive FDA 510(k) clearance?

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252941.

Who is the listed applicant for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

FDA 510(k)记录中列出O&M Halyard, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

The FDA product code for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is FXX.

列明O&M Halyard, 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。

K262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套 K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术 K253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹 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 K243604Halyard紫色丁腈-XTRA*无粉手套，低皮炎潜力，用于化疗药物，芬太尼盐酸盐和模拟胃酸中的芬太尼盐酸盐 K243172Halyard紫色丁腈*无粉手套，无菌套装；Halyard紫色丁腈*无粉手套，无菌单只

查看所有 26 个设备 →

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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