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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 K896411
Device Name REVISED PATIENT EXAMINATION GLOVES
Applicant
Pt. Trihasta Loka Persada
10, Jl. Suryopranoto
Jakarta - Indonesia,  ID
Applicant Contact JAMIN ADIWARNA
Correspondent
Pt. Trihasta Loka Persada
10, Jl. Suryopranoto
Jakarta - Indonesia,  ID
Correspondent Contact JAMIN ADIWARNA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/08/1989
Decision Date 12/20/1989
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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