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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K072197
Device Name POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
Applicant
Metacure Surgical Gloves Sdn Bhd
# 1, Jln 203, Off Jalan
Tandang
Petaling Jaya,  MY 46050
Applicant Contact AZMAN ISMAIL
Correspondent
Metacure Surgical Gloves Sdn Bhd
# 1, Jln 203, Off Jalan
Tandang
Petaling Jaya,  MY 46050
Correspondent Contact AZMAN ISMAIL
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LYY  
Date Received08/07/2007
Decision Date 03/12/2008
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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