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510(k) Data Aggregation

    K Number
    K250944
    Device Name
    Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
    Manufacturer
    GMP Medicare Sdn. Bhd.
    Date Cleared
    2025-04-23

    (26 days)

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

    GMP Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl
    Device Description
    Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
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