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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 K023977
Device Name PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
Applicant
Starmatrix Sdn Bhd
10, Jalan Ss 1/26
Petaling Jaya, Selangor,  MY 47300
Applicant Contact NGAN BOON SENG
Correspondent
Starmatrix Sdn Bhd
10, Jalan Ss 1/26
Petaling Jaya, Selangor,  MY 47300
Correspondent Contact NGAN BOON SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/02/2002
Decision Date 01/24/2003
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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