BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇱 Mali

    RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER

    K Number: K002114 · Decision Aug 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
    K Number
    K002114
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perusahaan Pelindung Getah (M) Sdn Bhd
    Date Received
    July 12, 2000
    Decision Date
    August 11, 2000
    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 Perusahaan Pelindung Getah (M) Sdn Bhd

    K Number Device Name
    K072300 POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
    K032201 RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
    K002111 RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
    K002112 RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
    K994201 RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K933759 RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED
    K891123 RUBBERCARE PATIENT EXAMINATION GLOVE