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

    PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES)

    K Number: K891815 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    145

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    Basic Information

    Device Name
    PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES)
    K Number
    K891815
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mulpha Intl. Trading Corp. Bhd.
    Date Received
    March 23, 1989
    Decision Date
    August 15, 1989
    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 Mulpha Intl. Trading Corp. Bhd.

    K Number Device Name
    K891812 PATIENT EXAM GLOVES (MFG. GETAH GAYAL)
    K891817 PATIENT EXAM GLOVES (MFG. TERANG NUSA)
    K891816 PATIENT EXAM GLOVES (MFG. HEALTHCARE GLOVES)
    K891811 PATIENT EXAM GLOVES (MFG. PALMBASE RUBBER MFG.)
    K891813 PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS)