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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 K213040
Device Name Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
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  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received09/22/2021
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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