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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 K211354
Device Name Disposable Synthetic Vinyl Nitrile Examination Glove
Applicant
Jiangsu Cureguard Glove Co., Ltd.
# 65 Shenzhen Rd., The Economic Development Zone
Suqian,  CN 223800
Applicant Contact Guo Hua
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
LYZ  
Subsequent Product Code
LZA  
Date Received05/03/2021
Decision Date 08/08/2021
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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