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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 K032007
Device Name GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
Applicant
PT. WRP BUANA MULTICORPORA
JALAN JERMAL #20B, KELURAHAN
SEI MATI, MEDAN LABUHAN KM 17
MEDAN,  ID 20252
Applicant Contact NG POY SIN
Correspondent
PT. WRP BUANA MULTICORPORA
JALAN JERMAL #20B, KELURAHAN
SEI MATI, MEDAN LABUHAN KM 17
MEDAN,  ID 20252
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/30/2003
Decision Date 07/28/2003
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
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