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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 K182528
Device Name Nitrile Glove Powder Free Black
Applicant
Haining Medical Products Co., Ltd.
West Of Dianchang Rd., Luannan County
Tangshan,  CN 063500
Applicant Contact Zhiming Yao
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 Received09/14/2018
Decision Date 11/15/2018
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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