FDA 510(k)

隔離衣 AAMI第3級

K 號：K212504 · 2021-11-07

決定日期2021-11-07

產品代碼FYC

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

Isolation Gown AAMI Level 3 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 2021-11-07 under 510(k) number K212504. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Isolation Gown AAMI Level 3?

Isolation Gown AAMI Level 3 is a medical device that received FDA 510(k) clearance on 2021-11-07. The listed applicant is Kenpax International Limited. The 510(k) number is K212504.

When did Isolation Gown AAMI Level 3 receive FDA 510(k) clearance?

Isolation Gown AAMI Level 3 received FDA 510(k) clearance on 2021-11-07, under 510(k) number K212504.

Who is the listed applicant for Isolation Gown AAMI Level 3?

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 Isolation Gown AAMI Level 3?

The FDA product code for Isolation Gown AAMI Level 3 is FYC.

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。

K222128防護袍 AAMI第4級 K222151消毒包 K202899程序口罩，外科口罩

相關器械（代碼：FYC）

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。

K232849Halyard 三層 AAMI 3 隔離衣，L，藍色（54310），Halyard 三層 AAMI 3 隔離衣，超加大，藍色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化療隔離袍Copioumed International, Inc.K223467一次性隔離衣Nanning Tecbod Biological Technology Co., Ltd.K223304一次性隔離袍（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Technology Co., Ltd.K223411一次性隔離袍（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等級3隔離袍Paneffort, LLC

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。