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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 K022987
Device Name LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
JL: K.H.MOH MANSYUR NO. 128
JAKARTA,  ID 11210
Applicant Contact LINGA SUMARTA
Correspondent
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
JL: K.H.MOH MANSYUR NO. 128
JAKARTA,  ID 11210
Correspondent Contact LINGA SUMARTA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/09/2002
Decision Date 10/21/2002
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
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