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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 K072614
Device Name MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
Applicant
Matang Mfg. Sdn. Bhd.
Lot 10, Kawasan Perindustrian
Serkam, Mukim Serkam
Jasin, Melaka,  MY 77300
Applicant Contact LESLIE LEONG
Correspondent
Matang Mfg. Sdn. Bhd.
Lot 10, Kawasan Perindustrian
Serkam, Mukim Serkam
Jasin, Melaka,  MY 77300
Correspondent Contact LESLIE LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/17/2007
Decision Date 04/15/2008
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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