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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 K952197
Device Name GLOVETEX (MULTIPLE)
Applicant
Pt Mbf Buana Multicorpora
J1. Sisingamangaraja, No 170
Medan,  ID 20217
Applicant Contact P OY SIN
Correspondent
Pt Mbf Buana Multicorpora
J1. Sisingamangaraja, No 170
Medan,  ID 20217
Correspondent Contact P OY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/09/1995
Decision Date 08/14/1995
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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