FDA 510(k)

一次性醫療口罩（耳環式）

K 號：K221196 · 2022-07-22

申請人Xiantao Topmed Nonwoven Protective Products Co., Ltd.

決定日期2022-07-22

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

Disposable Medical Face Mask (ear loop) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Topmed Nonwoven Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221196. 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 Disposable Medical Face Mask (ear loop)?

Disposable Medical Face Mask (ear loop) is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Xiantao Topmed Nonwoven Protective Products Co., Ltd.. The 510(k) number is K221196.

When did Disposable Medical Face Mask (ear loop) receive FDA 510(k) clearance?

Disposable Medical Face Mask (ear loop) received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221196.

Who is the listed applicant for Disposable Medical Face Mask (ear loop)?

The FDA 510(k) record lists Xiantao Topmed Nonwoven Protective Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Mask (ear loop)?

The FDA product code for Disposable Medical Face Mask (ear loop) is FXX.

其他以 Xiantao Topmed Nonwoven Protective Products 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。

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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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