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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 K212913
Device Name Surgical Face Mask
Applicant
Jiangxi Ganlong Pharmaceutical Co., Ltd.
# 164 Xiangjiang Ave. Ganzhou Economic And Technology
Development Zone
Ganzhou,  CN 341000
Applicant Contact Niansheng Liao
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz., W. Guangzhong Rd.
Shanghai,  CN 200071
Correspondent Contact Stuart Situ
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/13/2021
Decision Date 01/14/2022
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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