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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 K982877
Device Name MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
Applicant
Matang Mfg. Sdn. Bhd.
83-A, Jalan Langkasuka, Larkin
Industrial Area, 80350 Johor
Bahru Johor Darul Takzim,  MY
Applicant Contact RONALD LEONG
Correspondent
Matang Mfg. Sdn. Bhd.
83-A, Jalan Langkasuka, Larkin
Industrial Area, 80350 Johor
Bahru Johor Darul Takzim,  MY
Correspondent Contact RONALD LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/14/1998
Decision Date 11/30/1998
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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