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

    ROYAL SHIELD SHIELD GLOVES

    K Number: K926132 · Decision Dec 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    380

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    Basic Information

    Device Name
    ROYAL SHIELD SHIELD GLOVES
    K Number
    K926132
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
    Date Received
    December 7, 1992
    Decision Date
    December 22, 1993
    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 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.

    K Number Device Name
    K952588 ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES
    K952590 ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
    K952591 ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES
    K890907 ROYAL SHIELD LATEX EXAMINATION GLOVES(TM)