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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 K892789
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
P.T. Indo Rama Synthetics
Bangkok Bank Bldg., 6th Floor
Jln. M.H. Thamrin # 3
Jakarta Indonesia,  ID
Applicant Contact LAROYA
Correspondent
P.T. Indo Rama Synthetics
Bangkok Bank Bldg., 6th Floor
Jln. M.H. Thamrin # 3
Jakarta Indonesia,  ID
Correspondent Contact LAROYA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 07/14/1989
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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