FDA 510(k)

杜卡爾公司第三級外科口罩，配耳環，杜卡爾公司第三級外科口罩，可繫帶

K 號：K201732 · 2021-02-16

決定日期2021-02-16

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

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K201732. 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 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Dukal Corporation. The 510(k) number is K201732.

When did Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On receive FDA 510(k) clearance?

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On received FDA 510(k) clearance on 2021-02-16, under 510(k) number K201732.

Who is the listed applicant for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On?

The FDA product code for Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On is FXX.

其他以 Dukal Corporation 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。

K212464杜卡爾公司 AAMI 等級 4 開背保護袍 K210321杜卡爾公司第一級兒童口罩 K203237杜卡爾无菌AAMI等級3加強外科袍，无菌AAMI等級3外科袍，无菌AAMI等級4外科袍，以及无菌AAMI等級4縫合外科袍 K201421杜卡爾公司二級外科口罩（耳環式）；杜卡爾公司二級外科口罩（耳環式及臉盾）；杜卡爾公司二級外科口罩（可調節繩結式）

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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