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510(k) Data Aggregation

    K Number
    K230564
    Device Name
    Green Non Sterile Powder Free Nitrile Examination Gloves
    Manufacturer
    Central Medicare Sdn Bhd
    Date Cleared
    2023-05-23

    (83 days)

    Product Code
    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
    Green 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
    Green Non Sterile Powder Free Nitrile Examination Gloves
    Ask a Question
    K Number
    K213437
    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
    2022-04-11

    (171 days)

    Product Code
    LZA, LZC, 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 Fentaryl 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. 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. The following drugs and concentrations have been tested the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0 Azacitidine (Vidaza) 25.0 Bendamustine HCl 5.0 Bleomycin Sulfate 15.0 Busulfan 6.0 Carboplatin 10.0 Carfilzomib 2.0 Cetuximab 2.0 Chloroquine 50.0 Cisplatin 1.0 Cladribine 1.0 Cyclophosphamide (Cytoxan) 20.0 Cyclosporin A 100.0 Cytarabine 100.0 Cytovene (Ganciclovir) 10.0 Dacarbazine 10.0 Daunorubicin 5.0 Decitibine 5.0 Docetaxel 10.0 Doxorubicin Hydrochloride 2.0 Epirubicin (Ellence) 2.0 Etoposide (Toposar) 20.0 Fludarabine 25.0 Fluorouracil 50.0 Fulvestrant 50.0 Gemcitabine (Gemzar) 38.0 Idarubicin 1.0 Ifosfamide 50.0 Irinotecan 20.0 Mechlorethamine HCl 1.0 Melphalan 5.0 Mesna 50.0 Methotrexate 25.0 Mitomycin C 0.5 Mitoxantrone 2.0 Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8 The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes. Fentaryl 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. Gastric Acid Permeation Resistance Claim - 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 Fentaryl 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
    K211022
    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
    2021-12-22

    (261 days)

    Product Code
    LZA, LZC, 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. 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. Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine. WARNING: Do not use with Carmustine and Thiotepa. 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. Gastric Acid Permeation Resistance Claim - 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
    K203036
    Device Name
    Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
    Manufacturer
    Central Medicare Sdn Bhd
    Date Cleared
    2021-05-07

    (214 days)

    Product Code
    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
    Non Sterile Powder Free Polyurethane Examination Glove (Blue and Black colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
    Ask a Question
    K Number
    K143247
    Device Name
    Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
    Manufacturer
    CENTRAL MEDICARE SDN BHD
    Date Cleared
    2015-01-22

    (71 days)

    Product Code
    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
    Device Description
    Ask a Question
    K Number
    K113440
    Device Name
    HIGH FIVE
    Manufacturer
    CENTRAL MEDICARE SDN BHD
    Date Cleared
    2012-05-23

    (184 days)

    Product Code
    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
    A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
    Device Description
    The Nitrile Exam Gloves, Powder Free, Black, Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
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    K Number
    K103734
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
    Manufacturer
    CENTRAL MEDICARE SDN BHD
    Date Cleared
    2011-08-19

    (240 days)

    Product Code
    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
    A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)
    Ask a Question
    K Number
    K093696
    Device Name
    SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
    Manufacturer
    CENTRAL MEDICARE SDN BHD
    Date Cleared
    2010-02-12

    (74 days)

    Product Code
    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
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Blue Nitrile Examination Gloves, Powder Free
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