FDA 510(k)

醫療外科口罩（黑色口罩，第一級和第三級）

K 號：K213450 · 2022-04-05

申請人Guangdong Kingfa Sci. & Tech.Co., Ltd.

決定日期2022-04-05

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

Medical surgical mask (Black mask, Level 1 and Level 3) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-04-05 under 510(k) number K213450. 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 Medical surgical mask (Black mask, Level 1 and Level 3)?

Medical surgical mask (Black mask, Level 1 and Level 3) is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K213450.

When did Medical surgical mask (Black mask, Level 1 and Level 3) receive FDA 510(k) clearance?

Medical surgical mask (Black mask, Level 1 and Level 3) received FDA 510(k) clearance on 2022-04-05, under 510(k) number K213450.

Who is the listed applicant for Medical surgical mask (Black mask, Level 1 and Level 3)?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical surgical mask (Black mask, Level 1 and Level 3)?

The FDA product code for Medical surgical mask (Black mask, Level 1 and Level 3) is FXX.

其他以 Guangdong Kingfa Sci. & Tech.Co., Ltd. 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。

K233723醫療外科口罩 K231155可生物降解醫用外科口罩 K221983可生物降解無粉乳膠檢查手套，藍色，可生物降解無粉乳膠檢查手套，藍紫色，可生物降解無粉乳膠檢查手套，綠色 K230046乙烯檢查手套 K222612無粉乳膠檢查手套 K222714藍色丁腈病人檢查手套，適用於化學治療藥物檢驗，藍紫色丁腈病人檢查手套，適用於化學治療藥物檢驗，黑色丁腈病人檢查手套，適用於化學治療藥物檢驗

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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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