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510(k) Data Aggregation

    K Number
    K243694
    Device Name
    Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
    Manufacturer
    Mah Sing Healthcare Sdn. Bhd.
    Date Cleared
    2025-06-06

    (189 days)

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

    Mah Sing Healthcare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes | |---|---|---| | *Carmustine | 3.3mg/ml | 22.5 | | Cisplatin | 1 mg/ml | >240 | | Cyclophosphamide | 20 mg/ml | >240 | | Dacarbazine | 10 mg/ml | >240 | | Doxorubicin, HCl | 2 mg/ml | >240 | | Etoposide | 20 mg/ml | >240 | | Fluorouracil | 50 mg/ml | >240 | | Methotrexate | 25 mg/ml | >240 | | Mitomycin | 0.5 mg/ml | >240 | | Oxaliplatin | 5 mg/ml | >240 | | Paclitaxel | 6 mg/ml | >240 | | *Thiotepa | 10 mg/ml | 34.5 | | Vincristine | 1 mg/ml | >240 | | Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes | |---|---|---| | Fentanyl Citrate Injection | 100mcg/2ml | >240 | **Warning:** Do not use with Carmustine and Thiotepa. ***Note:*** Please note that the following drugs have low permeation times: (1) Carmustine - 22.5 minutes (2) Thiotepa - 34.5 minutes.
    Device Description
    The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves. The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
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