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510(k) Data Aggregation

    K Number
    K230681
    Device Name
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2023-10-02

    (203 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
    Device Description
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
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    K Number
    K223752
    Device Name
    Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2023-07-24

    (221 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).
    Device Description
    Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Ask a Question
    K Number
    K230875
    Device Name
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2023-07-20

    (112 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
    Device Description
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Ask a Question
    K Number
    K183149
    Device Name
    Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2019-07-04

    (233 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
    Device Description
    Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim
    Ask a Question
    K Number
    K173942
    Device Name
    Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2018-03-05

    (69 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
    Device Description
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
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    K Number
    K172642
    Device Name
    Orange Non Sterile Powder Free Nitrile Examination Gloves
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2017-11-28

    (88 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.
    Ask a Question
    K Number
    K172525
    Device Name
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Central Medicare Sdn. Bhd.
    Date Cleared
    2017-11-13

    (84 days)

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

    Central Medicare Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
    Device Description
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
    Ask a Question

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