FDA 510(k)

一次性外科隔離衣

K 號：K212422 · 2022-04-29

申請人Crown Name Disposable Hygiene Products Fty., Ltd.

決定日期2022-04-29

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

Disposable Surgical Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K212422. 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 Disposable Surgical Isolation Gown?

Disposable Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K212422.

When did Disposable Surgical Isolation Gown receive FDA 510(k) clearance?

Disposable Surgical Isolation Gown received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212422.

Who is the listed applicant for Disposable Surgical Isolation Gown?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Isolation Gown?

The FDA product code for Disposable Surgical Isolation Gown is FYC.

其他以 Crown Name Disposable Hygiene Products Fty., 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。

K203534外科口罩（型號：平面耳環/CN102）

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。