FDA 510(k)

防護袍 AAMI第4級

K 號：K222128 · 2023-08-08

決定日期2023-08-08

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

Protective Gown AAMI Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K222128. 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 Protective Gown AAMI Level 4?

Protective Gown AAMI Level 4 is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Kenpax International Limited. The 510(k) number is K222128.

When did Protective Gown AAMI Level 4 receive FDA 510(k) clearance?

Protective Gown AAMI Level 4 received FDA 510(k) clearance on 2023-08-08, under 510(k) number K222128.

Who is the listed applicant for Protective Gown AAMI Level 4?

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

What is the FDA product code for Protective Gown AAMI Level 4?

The FDA product code for Protective Gown AAMI Level 4 is QPC.

其他以 Kenpax International Limited 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。

K222151消毒包 K212504隔離衣 AAMI第3級 K202899程序口罩，外科口罩

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

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