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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 K970115
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Pt Mbf Buana Multicorpora
J1. Sisingamangaraja, No 170
Medan,  ID 20217
Applicant Contact NG POY SIN
Correspondent
Pt Mbf Buana Multicorpora
J1. Sisingamangaraja, No 170
Medan,  ID 20217
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/13/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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