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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 K942855
Device Name NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Evergrade Healthcare Products Sdn Bhd
1st Floor,Wisma Selamat,16
Jalan Salleh
Muar Johor,  MY 84000
Applicant Contact NG LEE SEN
Correspondent
Evergrade Healthcare Products Sdn Bhd
1st Floor,Wisma Selamat,16
Jalan Salleh
Muar Johor,  MY 84000
Correspondent Contact NG LEE SEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/16/1994
Decision Date 11/15/1995
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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