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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 K965155
Device Name LATEX EXAM GLOVES
Applicant
P.T. Irama Dinamika Latex
630 S. Grand Ave., Unit 112
Santa Ana,  CA  92701
Applicant Contact ABRAHAM KURIAN
Correspondent
P.T. Irama Dinamika Latex
630 S. Grand Ave., Unit 112
Santa Ana,  CA  92701
Correspondent Contact ABRAHAM KURIAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/23/1996
Decision Date 03/05/1997
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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