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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K101103
Device Name POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
Applicant
BEST PUTRA GLOVES SDN BHD
MOHD TAIB, KAWASAN
PERINDUSTRIAN
SG CHOH RAWANG, SELANGOR,  MY 48000
Applicant Contact EFFENDI TENANG
Correspondent
BEST PUTRA GLOVES SDN BHD
MOHD TAIB, KAWASAN
PERINDUSTRIAN
SG CHOH RAWANG, SELANGOR,  MY 48000
Correspondent Contact EFFENDI TENANG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/20/2010
Decision Date 07/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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