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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 K892636
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
P.T. Latexindo Parama
Jln. Dr. Wahidin No: 32.
Medan. 20211, N. Sumatra
Indonesia,  ID
Applicant Contact PIET JAYALIE
Correspondent
P.T. Latexindo Parama
Jln. Dr. Wahidin No: 32.
Medan. 20211, N. Sumatra
Indonesia,  ID
Correspondent Contact PIET JAYALIE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 12/11/1989
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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