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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 K222651
Device Name Surgical Face Mask
Applicant
Xiantao Sanda Industrial Co., Ltd.
# 46 Golden Ave.
Xiantao,  CN 433000
Applicant Contact Rong Min
Correspondent
Purefda
111 Town Sq. Pl.
Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Bryan Wong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/01/2022
Decision Date 12/13/2022
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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