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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
Device Name MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
Applicant
Shanghai Motex Healthcare Co., Ltd.
# 369, Jiasong Zhong Rd.
Huaxin, Qingpu
Shanghai,  CN 201708
Applicant Contact JEN KE-MIN
Correspondent
Shanghai Motex Healthcare Co., Ltd.
# 369, Jiasong Zhong Rd.
Huaxin, Qingpu
Shanghai,  CN 201708
Correspondent Contact JEN KE-MIN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/22/2012
Decision Date 10/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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