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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K212002
Device Name Synthetic Vinyl Examination Gloves
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.1801,#161,East Lu Jiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/28/2021
Decision Date 09/23/2021
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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