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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K222612
Device Name Powder-Free Latex examination gloves
Applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.
# 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Applicant Contact Xiaoge Yu
Correspondent
Guangdong Kingfa Sci. & Tech.Co., Ltd.
# 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Correspondent Contact Xiaoge Yu
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/30/2022
Decision Date 11/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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