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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 K121335
Device Name G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
Applicant
HUTCHINSON SANTE S.N.C.
RUE MARRET PATUREL
LIANCOURT,  FR F-60140
Applicant Contact RAFFI KRIKORIAN
Correspondent
HUTCHINSON SANTE S.N.C.
RUE MARRET PATUREL
LIANCOURT,  FR F-60140
Correspondent Contact RAFFI KRIKORIAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/03/2012
Decision Date 09/13/2012
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
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