FDA 510(k)

一次性外科口罩（非无菌）(EFX3PLBLKMSK300)

K 號：K253398 · 2026-02-19

決定日期2026-02-19

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 Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is the device name listed in this FDA 510(k) record. The listed applicant is Efofex, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K253398. 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 Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Efofex, Inc.. The 510(k) number is K253398.

When did Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) receive FDA 510(k) clearance?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253398.

Who is the listed applicant for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

The FDA 510(k) record lists Efofex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

The FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is FXX.

其他以 Efofex, Inc. 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。

K223823一次性外科口罩

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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