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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 K160781
Device Name Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
Applicant
Semperit Investments Asia Pte , Ltd.
8 Jurong Town Hall Rd. #29 - 03 To 06 Jtc Summit
Singapore,  SG 609434
Applicant Contact CLEMENS EICHLER
Correspondent
Benjamin L. England & Associates, LLC
810 Landmark Dr. Suite 126
Glen Burnie,  MD  21061
Correspondent Contact THOMAS C. KNOTT
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/22/2016
Decision Date 05/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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