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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 K213048
Device Name Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
Applicant
Huayuan Medical Technology(Shangqiu) Co., Ltd.
In The N. Yard Of W. 1000m Rd. At
The Intersection Of Zhuangzhou Ave. And Pingyuan R
Shangqiu,  CN 476000
Applicant Contact Huamei Wang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/22/2021
Decision Date 12/18/2021
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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