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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    K Number: K022987 · Decision Oct 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    21
    Review Days
    42

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    Basic Information

    Device Name
    LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
    K Number
    K022987
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Arista Latindo Industrial Ltd. P.T
    Date Received
    September 9, 2002
    Decision Date
    October 21, 2002
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    Other Clearances by Arista Latindo Industrial Ltd. P.T

    K Number Device Name
    K041745 VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
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    K031913 VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
    K030245 NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
    K023754 VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
    K023753 VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
    K023072 POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
    K021412 LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
    K013320 BLUE LATEX EXAMINATION GLOVES, POWDER FREE
    K002745 VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
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