FDA 510(k)

杜卡爾公司 AAMI 等級 4 開背保護袍

K 號：K212464 · 2022-03-30

決定日期2022-03-30

產品代碼QPC

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 AAMI Level 4 Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K212464. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Dukal Corporation. The 510(k) number is K212464.

When did Dukal Corporation AAMI Level 4 Open-Back Protective Gown receive FDA 510(k) clearance?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown received FDA 510(k) clearance on 2022-03-30, under 510(k) number K212464.

Who is the listed applicant for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

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 AAMI Level 4 Open-Back Protective Gown?

The FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown is QPC.

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。

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 K201732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 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：QPC）

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。

K262007PRIMED AAMI等級3開背袍PRIMED Medical Products, Inc.K261115VR®個人防護等級4袍子（VR袍子）PolyConversions, Inc.K252940VR®個人防護等級3袍子（VR袍子）PolyConversions, Inc.K242689AAMI 等級 4 保護；大褲Azac Group K233526美林開放式3級保護衣Medline Industries, LP K230384PolyWear® 個人防護等級3袍子PolyConversions, 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。