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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K083624
Device Name POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Applicant
Comfort Rubber Gloves Ind. Sdn. Bhd.
Lot 821, Jalan Matang
34750 Matang
Taiping, Perak,  MY
Applicant Contact TAN K BENG
Correspondent
Comfort Rubber Gloves Ind. Sdn. Bhd.
Lot 821, Jalan Matang
34750 Matang
Taiping, Perak,  MY
Correspondent Contact TAN K BENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/08/2008
Decision Date 02/10/2009
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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