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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 K203436
Device Name Disposable Nitrile Examination Gloves
Applicant
Shandong Zhushi Pharmaceutical Group Co., Ltd
No. 6 Shande Road
Shan County
Heze,  CN 274300
Applicant Contact Junhui Zhu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Room 608, No. 738, Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/23/2020
Decision Date 04/28/2021
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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