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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 K212398
Device Name Surgical Face Mask (Non-sterile)
Applicant
Hubei Kimsoul Industrial Co., Ltd.
# 1, Industrial Zone, Guohe Town
Xiantao,  CN 433013
Applicant Contact Faming Zhang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/02/2021
Decision Date 12/15/2021
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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