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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 K212036
Device Name Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
Applicant
Jiangsu Yanfang Medical Technology Co., Ltd.
#16, Kaiyuan Rd., Changjing Town, Jiangyin,
Wuxi, Jiangsu, China  
Wuxi,  CN 214411
Applicant Contact Kaijian Wei
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received06/30/2021
Decision Date 10/05/2021
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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