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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 K213688
Device Name Nitrile Examination Gloves (Model: ZMG1351)
Applicant
Wuhan Zonsen Medical Products Co., Ltd.
No 8 Jinchao Rd., Zhucheng St., Xinzhou District
Wuhan,  CN 431400
Applicant Contact Cynthia Ye
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/23/2021
Decision Date 02/18/2022
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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