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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K210391
Device Name Single-use medical face mask
Applicant
Zhuhai Herald Datanetics Limited.
Bldg.#2, #1 Pingxi Rd. 6, Nanping Science And
Technology Industrial Park
Zhuhai,  CN 519060
Applicant Contact Jackson Leung
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/10/2021
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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