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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K173053
Device Name POWDER FREE LATEX EXAMINATION GLOVE
Applicant
Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial
Kamunting,  MY 34600
Applicant Contact Yoon Lim Kok
Correspondent
Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial
Kamunting,  MY 34600
Correspondent Contact Terence Lim
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/28/2017
Decision Date 06/06/2018
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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