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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K171378
Device Name Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
Applicant
Semperit Investments Asia Pte , Ltd.
8 Jurong Town Hall Rd., #29-03 To 06 The Jtc Summit
Singapore,  SG
Applicant Contact Clemens Eichler
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received05/10/2017
Decision Date 09/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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