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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 K222937
Device Name Disposable 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. 1801, # 16 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/26/2022
Decision Date 10/01/2022
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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