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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 K210686
Device Name Nitrile Patient Examination Glove
Applicant
Yunnan Huazhiyuan Medical Technology Co., Ltd.
Yangjie Industrial Park,Jianshui County
Honghe Hani And Yi Autonomous Prefecture,  CN 654300
Applicant Contact Yun Gao
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/08/2021
Decision Date 07/21/2021
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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