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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 K211028
Device Name Nitrile Patient Examination Gloves
Applicant
Huayuan Medical Technology(Shangqiu) Co., Ltd.
In The N. Yard Of W. 1000m Rd. At The Intersection Of
Zhuangzhou Ave. And Pingyuan Rd., Liangyuan District
Shangqiu,  CN 476000
Applicant Contact Huamei Wang
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 Received04/06/2021
Decision Date 06/04/2021
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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