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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 K171667
Device Name Powder Free Nitrile 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
LZA  
Date Received06/05/2017
Decision Date 09/08/2017
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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