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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 K183441
Device Name Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and 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 Central,  SG 609434
Applicant Contact Andreas Woess
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Court
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received12/12/2018
Decision Date 10/04/2019
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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