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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 K191860
Device Name Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
Applicant
Semperit Technische Produkte Gesellchaft M.B.H.
Triester Bundesstrasse 26
Wimpassing,  AT 2632
Applicant Contact Andreas Woess
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/11/2019
Decision Date 03/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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