FDA 510(k)

第二級標準外科袍、第三級標準外科袍、第三級加強外科袍

K 號：K211422 · 2021-07-02

申請人Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

決定日期2021-07-02

產品代碼FYA

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

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K211422. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. The 510(k) number is K211422.

When did Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown receive FDA 510(k) clearance?

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown received FDA 510(k) clearance on 2021-07-02, under 510(k) number K211422.

Who is the listed applicant for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

The FDA 510(k) record lists Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown?

The FDA product code for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown is FYA.

其他以 Jiangsu Medplus Non-Woven Manufacturer Co., 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。

K202605標準程序口罩，標準外科口罩

相關器械（代碼：FYA）

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。

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官方來源

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