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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 K143289
Device Name NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
Applicant
Yty Industry (Manjung) Sdn Bhd
Lot 1422-1424
Batu 10 Lekir
Sitiawan,  MY 32020
Applicant Contact Arivagalan Subramaniam
Correspondent
Yty Industry (Manjung) Sdn Bhd
Lot 1422-1424
Batu 10 Lekir
Sitiawan,  MY 32020
Correspondent Contact Punitha Samy
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/17/2014
Decision Date 08/18/2015
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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