FDA 510(k)

使い捨て耳ひも式医療用マスク、使い捨て留め具式医療用マスク

K番号: K211462 · 2021-08-19

申請者Xiantao S&J Protective Products Co., Ltd.

決定日2021-08-19

製品コードFXX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao S&J Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211462. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Xiantao S&J Protective Products Co., Ltd.. The 510(k) number is K211462.

When did Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask receive FDA 510(k) clearance?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211462.

Who is the listed applicant for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

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

What is the FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

The FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is FXX.

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使い捨て耳ひも式医療用マスク、使い捨て留め具式医療用マスク

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FXX）

公式ソース