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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 K223004
Device Name Disposable Nitrile Examination Gloves
Applicant
Jiangxi Handspro Products Solutions Co., Ltd.
Chuangye Ave., Fenglin Industrial Zone Of Dean County
Jiujiang City,  CN 330406
Applicant Contact Jun Yin
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/29/2022
Decision Date 12/04/2022
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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