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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 K142283
Device Name Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
Applicant
Yty Industry (Manjung) Sdn Bhd
Lot 1422-1424
Batu 10 Lekir
Sitiawan,  MY 32020
Applicant Contact Arivalagan Subramaniam
Correspondent
Qa/Gmp Consultant
14004 Manor Rd.
P.O. Box 445
Phonex,  MD  21131 -0045
Correspondent Contact Andrew Lowery
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/15/2014
Decision Date 01/16/2015
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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