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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 K994426
Device Name GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
Applicant
PT. WRP BUANA MULTICORPORA
JALAN JERMAL NO. 20
KELURAHAN SEI MATI
MEDAN-LABUHAN,  ID
Applicant Contact NG POY SIN
Correspondent
PT. WRP BUANA MULTICORPORA
JALAN JERMAL NO. 20
KELURAHAN SEI MATI
MEDAN-LABUHAN,  ID
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/30/1999
Decision Date 05/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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