BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    HIGH RISK GLOVES

    K Number: K955241 · Decision May 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    9
    Review Days
    195

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    Basic Information

    Device Name
    HIGH RISK GLOVES
    K Number
    K955241
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pan-Century Rubber Products Sdn. Bhd.
    Date Received
    November 15, 1995
    Decision Date
    May 28, 1996
    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 Pan-Century Rubber Products Sdn. Bhd.

    K Number Device Name
    K993183 POWDER FREE GLOVES (POLYMER COATED)
    K993287 POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K981164 POWDER FREE CHLORINATED GLOVES-(TEXTURED)
    K924633 HYPOALLERGENIC LATEX GLOVES
    K910046 PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES
    K910047 PATIENT EXAMINATION GLOVES-TEXTURED GLOVES
    K910045 PATIENT EXAMINATION GLOVES-POWDER FREED
    K894375 PATIENT EXAMINATION GLOVES