FDA 510(k)

外科口罩

K 號：K212120 · 2022-01-28

決定日期2022-01-28

產品代碼FXX

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

Surgical Masks is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K212120. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Masks?

Surgical Masks is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K212120.

When did Surgical Masks receive FDA 510(k) clearance?

Surgical Masks received FDA 510(k) clearance on 2022-01-28, under 510(k) number K212120.

Who is the listed applicant for Surgical Masks?

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

What is the FDA product code for Surgical Masks?

The FDA product code for Surgical Masks is FXX.

其他以 Hubei Xinxin Non-Woven 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。

K253003非无菌級別3外科袍（4025）；无菌級別3外科袍（M4025）；非无菌加強級別4外科袍（G4025）；加強无菌級別4外科袍（GM4025）K214116AAMI4 隔離大褲 K213832AAMI3 隔離大褲

相關器械（代碼：FXX）

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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