LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K211360
    Device Name
    Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
    Manufacturer
    Pt. Universal Gloves
    Date Cleared
    2022-01-15

    (257 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pt. Universal Gloves

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free nitrile examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.
    Device Description
    Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
    Ask a Question

    Ask a specific question about this device

    K Number
    K203074
    Device Name
    Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
    Manufacturer
    PT. Universal Gloves
    Date Cleared
    2021-11-19

    (406 days)

    Product Code
    LYYLZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PT. Universal Gloves

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Latex Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination. Disposable Nitrile Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K201576
    Device Name
    Disposable Latex Powder Free Examination Gloves (Non-sterile)
    Manufacturer
    PT. Universal Gloves
    Date Cleared
    2021-05-19

    (342 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PT. Universal Gloves

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.
    Device Description
    Disposable Latex Powder Free Examination Gloves (Non-sterile)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1