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

    POWDER FREE CHLORINATED GLOVES-(TEXTURED)

    K Number: K981164 · Decision Apr 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    POWDER FREE CHLORINATED GLOVES-(TEXTURED)
    K Number
    K981164
    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
    March 31, 1998
    Decision Date
    April 23, 1998
    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
    K955241 HIGH RISK GLOVES
    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