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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 K223068
Device Name Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
Applicant
Guangdong Golden Leaves Technology Development Co., Ltd.
5/F, Bldg. 2, # 8, Qiaolonghe E. Rd.
Tangxia Town
Dongguan,  CN 523730
Applicant Contact Wenhong Zhou
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.
Huangpu District
Guangzhou,  CN 523000
Correspondent Contact Cassie Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/30/2022
Decision Date 11/23/2022
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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