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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 K893158
Device Name TOPCLEAN PATIENT EXAMINATION GLOVES
Applicant
Pt. Herlin Dharma Persada
Jl. Sukarjo Wiryopranoto 42
Jakarta,  ID
Applicant Contact HERMAN KURNIADJAJA
Correspondent
Pt. Herlin Dharma Persada
Jl. Sukarjo Wiryopranoto 42
Jakarta,  ID
Correspondent Contact HERMAN KURNIADJAJA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/14/1989
Decision Date 09/13/1989
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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