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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgeon's gloves
510(k) Number K122557
Model 6610,6710,6810,6910
Device Name MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
Original Applicant
SHANGHAI MOTEX HEALTHCARE CO., LTD.
no. 369, jiasong zhong road
huaxin, qingpu
shanghai,  CH 201708
Original Contact jen ke-min
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/22/2012
Decision Date 10/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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