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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 K203702
Device Name Vinyl Examination Gloves (Yellow)
Applicant
Xinying Trading CO., LTD.
Garden Street
Dezhou,  CN 253000
Applicant Contact Tongguang Liu
Correspondent
Shanghai Truthful information Technology Co., Ltd.
RM.608, No.738, Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/18/2020
Decision Date 02/12/2021
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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