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510(k) Data Aggregation

    K Number
    K220644
    Device Name
    Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
    Manufacturer
    YTY Industry (Manjung) Sdn Bhd
    Date Cleared
    2023-03-25

    (386 days)

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

    YTY Industry (Manjung) Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.
    Device Description
    Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
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    K Number
    K202536
    Device Name
    Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    YTY Industry (Manjung) SDN BHD
    Date Cleared
    2021-08-11

    (344 days)

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

    YTY Industry (Manjung) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Aloe Vera: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, and Vincristine Sulfate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA. Non-Sterile, Powder Free Nitrile Examination Gloves: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, Vincristine Sulfate, and Fentanyl Citrate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.
    Device Description
    Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.
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    K Number
    K200453
    Device Name
    NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
    Manufacturer
    YTY Industry (Manjung) Sdn Bhd
    Date Cleared
    2020-05-01

    (67 days)

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

    YTY Industry (Manjung) Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Blue | | |--------------------------------------------|-----------------------------------------------| | Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) | | Carboplatin, 10 mg/ml | > 240 minutes | | Carmustine, 3.3 mg/ml | 11.3 minutes | | Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes | | Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes | | Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes | | Etoposide (Toposar), 20.0 mg/ml | > 240 minutes | | Fluorouracil, 50.0 mg/ml | > 240 minutes | | Ifosfamide, 50.0 mg/ml | > 240 minutes | | Methotrexate, 25 mg/ml | > 240 minutes | | Mitomycin C, 0.5 mg/ml | > 240 minutes | | Mitoxantrone, 2 mg/ml | > 240 minutes | | Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes | | ThioTEPA, 10.0 mg/ml | 7.4 minutes | | Vincristine Sulfate, 1.0 mg/ml | > 240 minutes | The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA A patient 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate: | Blue | | |--------------------------------------------|-----------------------------------------------| | Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) | | Carboplatin, 10 mg/ml | > 240 minutes | | Carmustine, 3.3 mg/ml | 30.3 minutes | | Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes | | Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes | | Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes | | Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes | | Etoposide (Toposar), 20.0 mg/ml | > 240 minutes | | Fluorouracil, 50.0 mg/ml | > 240 minutes | | Ifosfamide, 50.0 mg/ml | > 240 minutes | | Methotrexate, 25 mg/ml | > 240 minutes | | Mitomycin C, 0.5 mg/ml | > 240 minutes | | Mitoxantrone, 2 mg/ml | > 240 minutes | | Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes | | ThioTEPA, 10.0 mg/ml | 91.0 minutes | | Vincristine Sulfate, 1.0 mg/ml | > 240 minutes | | Busulfan, 6 mg/ml | > 240 minutes | | Cytarabine, 100 mg/ml | > 240 minutes | | Daunorubicin, 5 mg/ml | > 240 minutes | | Docetaxel, 10 mg/ml | > 240 minutes | | Epirubicin, 2 mg/ml | > 240 minutes | | Gemcitabine, 38 mg/ml | > 240 minutes | | Irinotecan Hydrochloride, 20 mg/ml | > 240 minutes | | Mechlorethamine HCL, 1.0 mg/ml | > 240 minutes | | Melphalan, 5 mg/ml | > 240 minutes | | Trisenox, 0.1 mg/ml | > 240 minutes | | Fentanyl Citrate, 100mcg/2ml | > 240 minutes | The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS
    Device Description
    Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
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    K Number
    K182383
    Device Name
    Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
    Manufacturer
    YTY Industry (Manjung) Sdn Bhd
    Date Cleared
    2019-03-19

    (200 days)

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

    YTY Industry (Manjung) Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient 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.
    Device Description
    Non-Sterile, PF Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs - Blue
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    K Number
    K171104
    Device Name
    Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
    Manufacturer
    YTY INDUSTRY (MANJUNG) SDN BHD
    Date Cleared
    2017-08-25

    (134 days)

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

    YTY INDUSTRY (MANJUNG) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
    Device Description
    Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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