外科口罩（耳掛式）
K 號：K252534 · 2026-03-03
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決定日期2026-03-03
產品代碼FXX
諮詢委員會SU
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決定相當於
器材摘要
Surgical Face Mask (Ear mount) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K252534. 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 Surgical Face Mask (Ear mount)?
Surgical Face Mask (Ear mount) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. The 510(k) number is K252534.
When did Surgical Face Mask (Ear mount) receive FDA 510(k) clearance?
Surgical Face Mask (Ear mount) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K252534.
Who is the listed applicant for Surgical Face Mask (Ear mount)?
The FDA 510(k) record lists Zhejiang Hangkang Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surgical Face Mask (Ear mount)?
The FDA product code for Surgical Face Mask (Ear mount) is FXX.
相關臨床試驗
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。
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.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.K252941HALYARD*成人臉罩，內層及耳帶均採用SO SOFT*材質O&M Halyard, Inc.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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