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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 K896604
Device Name MAL LATEX EXAMINATION GLOVES
Applicant
Pt. Maja Agung Latexindo
Jalan Asia No: 6-B Medan-20214
Sumatera-Utara
Indonesia,  ID
Applicant Contact KENNRY PURWONO
Correspondent
Pt. Maja Agung Latexindo
Jalan Asia No: 6-B Medan-20214
Sumatera-Utara
Indonesia,  ID
Correspondent Contact KENNRY PURWONO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/21/1989
Decision Date 01/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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