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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 K101106
Device Name POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
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 Number880.6250
Classification Product Code
LYY  
Date Received04/20/2010
Decision Date 11/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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