FDA 510(k)

第3級濾水性術後口罩（型號：15604F，1570F）

K 號：K211827 · 2021-09-23

申請人Zhejiang Lanhine Medical Products, Ltd.

決定日期2021-09-23

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

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211827. 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 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211827.

When did Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) receive FDA 510(k) clearance?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211827.

Who is the listed applicant for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

The FDA 510(k) record lists Zhejiang Lanhine Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

The FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is FXX.

其他以 Zhejiang Lanhine Medical Products, 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。

K211832防濺術術口罩，防濺手術口罩

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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