Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183280
    Device Name
    PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
    Date Cleared
    2019-07-26

    (245 days)

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

    Smart Glove Corporation Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
    Device Description
    PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for Use with Chemotherapy Drugs.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1