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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 K231029
Device Name Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Applicant
Zhonghong Pulin Medical Products Co., Ltd.
West Industrial Park, Luannan County
Tangshan,  CN 063500
Applicant Contact Li Yunjiao
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  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received04/11/2023
Decision Date 10/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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