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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 K912040
Device Name LATEX EXAMINATION GLOVES
Applicant
PT. INDORAYA EVERLATEX
JLN.A.YANI KM.22 LANDASAN ULIN
BANJARBARU KALIMANTAN-SELATAN
INDONESIA(KODE POS 70723),  ID
Applicant Contact TEDJO DJTMIKO
Correspondent
PT. INDORAYA EVERLATEX
JLN.A.YANI KM.22 LANDASAN ULIN
BANJARBARU KALIMANTAN-SELATAN
INDONESIA(KODE POS 70723),  ID
Correspondent Contact TEDJO DJTMIKO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/08/1991
Decision Date 12/09/1991
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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