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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 K140989
Device Name POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
Applicant
Hebei Hongsen Plastics Technology Co, Ltd.
853 Dorchester Ln, Unitb
New Milford,  NJ  07646
Applicant Contact CHARLES SHEN
Correspondent
Hebei Hongsen Plastics Technology Co, Ltd.
853 Dorchester Ln, Unitb
New Milford,  NJ  07646
Correspondent Contact CHARLES SHEN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/17/2014
Decision Date 12/22/2014
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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