BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Great Glove

    DI: B754SBLKNM520E0 · Model: SBLK-NM520E · GD CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Great Glove
    Primary DI
    B754SBLKNM520E0
    Version / Model
    SBLK-NM520E
    Company Name
    GD CARE INC.
    Labeler DUNS
    080925610
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-07
    Public Version
    2
    Public Version Date
    2023-04-10
    Public Version Status
    Update
    Public Device Record Key
    c411689f-671e-4d11-8fb7-5700a4fe2eac

    Device Description

    Black Nitrile Powder Free Medical Gloves Size Extra Large

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove

    GMDN Terms

    Code Name
    56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Package B754SBLKNM520E1
    Primary B754SBLKNM520E0
    Package B754SBLKNM520E2

    Premarket Submissions

    Submission Number Supplement Number
    K182528 000
    K213121 000