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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 K212014
Device Name Medical Nitrile Examination Gloves
Applicant
Jiangxi Ronglai Medical Technology Co., Ltd.
#666 Baixu St., Baixu Town, Jinxian County
Nanchang,  CN 331701
Applicant Contact Hailin Shu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/28/2021
Decision Date 10/13/2021
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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