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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 K925683
Device Name NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
Applicant
Arista Latindo Industrial Ltd. P.T
P.O. Box 1129 Jakarta
Indonesia,  ID
Applicant Contact GENTHO SUMARTA
Correspondent
Arista Latindo Industrial Ltd. P.T
P.O. Box 1129 Jakarta
Indonesia,  ID
Correspondent Contact GENTHO SUMARTA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/03/1992
Decision Date 06/04/1993
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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