FDA 510(k)

HALYARD成人臉罩，內層及耳帶均採用SO SOFT材質

K 號：K252941 · 2025-12-11

決定日期2025-12-11

產品代碼FXX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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) 記錄將 O&M Halyard, Inc. 列為申請人。這並不單獨確立設備製造商。

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.

其他以 O&M Halyard, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262014PUREZERO* MARIN* 硅膠無粉檢查手套；PUREZERO* MARIN-XTRA* 硅膠無粉檢查手套 K261897HALYARD* ARMOR-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* HEAVY-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* STANDARD-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* H300W 過濾包裝帶，配備ASSURE-DRY* 技術 K253454HALYARD* 一步式* 消毒包材；HALYARD* 快速檢查* 消毒包材；HALYARD* 逐序* 消毒包材；HALYARD* 智能折* 消毒包材 K251967HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶；HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶，並附帶 WrapAround Visor。K243604Halyard紫色硝基橡胶-XTRA*無粉檢查手套，低皮膚炎潛在風險，已檢測可與化療藥物、芬太尼鹽酸及芬太尼鹽酸在模擬胃酸中使用 K243172Halyard 紫色丁腈* 非粉塵檢查手套，無菌成對；Halyard 紫色丁腈* 非粉塵檢查手套，無菌單只

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相關器械（代碼：FXX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251967HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶；HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶，並附帶 WrapAround Visor。O&M Halyard, Inc.K252534外科口罩（耳掛式）Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性外科口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性醫療口罩Makrite Industries, Inc.K243342KP防護口罩Kp Trading Co., Ltd.

官方來源

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