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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 K023522
Device Name EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
Applicant
Ever-More Latex Products Sdn Bhd
Lot 555, 6 3/4 Mile
Jalan Gangsa, Durian Tunggall
Melaka,  MY 76100
Applicant Contact CHIA MENG CHANG
Correspondent
Ever-More Latex Products Sdn Bhd
Lot 555, 6 3/4 Mile
Jalan Gangsa, Durian Tunggall
Melaka,  MY 76100
Correspondent Contact CHIA MENG CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/21/2002
Decision Date 11/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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