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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K221983
Device Name Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
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
LZA  
Date Received07/06/2022
Decision Date 04/27/2023
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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