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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 K250313
Device Name Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
Applicant
Harps Europe Manufacturing GmbH
Triester Bundesstrasse 26
Wimpassing Niederosterreich
Niederosterreich,  AT 2632
Applicant Contact Alexander Weinert
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received02/03/2025
Decision Date 08/19/2025
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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