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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 K010356
Device Name LATEX EXAMINATION GLOVES-POWDER FREE
Applicant
Enzymic Technologies Sdn Bhd
Air Keroh Industrial Estate
Melaka,  MY 75450
Applicant Contact LEE HONG YEN
Correspondent
Enzymic Technologies Sdn Bhd
Air Keroh Industrial Estate
Melaka,  MY 75450
Correspondent Contact LEE HONG YEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/05/2001
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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