LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242936
    Device Name
    Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Sunray Medical Products Inc.
    Date Cleared
    2025-01-15

    (112 days)

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

    Sunray Medical Products Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).
    Device Description
    The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1