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510(k) Data Aggregation

    K Number
    K211621
    Device Name
    Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-10-06

    (133 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Careplus (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Latex Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less)
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    K Number
    K201857
    Device Name
    Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-08-20

    (410 days)

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

    Careplus (M) 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 or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large.
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    K Number
    K203705
    Device Name
    Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-08-20

    (245 days)

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

    Careplus (M) 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 or finger to prevent contamination between patient and examiner.
    Device Description
    The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.
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    K Number
    K210724
    Device Name
    ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-08-03

    (146 days)

    Product Code
    KGO, LZC
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Careplus (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: | Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minute | |----------------------------------------|-----------------------------------------------| | Fluorouracil (50.0mg/ml) | >240 | | Etoposide (20.0mg/ml) | >240 | | Cyclophosphamide (20.0mg/ml) | >240 | | Carmustine (3.3mg/ml) | 14.1 | | Thiotepa (10.0mg/ml) | 16.9 | | Paclitaxel (6.0mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0mg/ml) | >240 | | Methotrexate (25.0mg/ml) | >240 | | Vincristine Sulfate (1.0mg/ml) | >240 | "WARNING: Do not use with Carmustine and Thiotepa"
    Device Description
    It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.
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    K Number
    K210656
    Device Name
    ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-06-24

    (112 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Careplus (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: | Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes | |----------------------------------------|---------------------------------------------------| | Fluorouracil (50.0mg/ml) | >240 | | Etoposide (20.0mg/ml) | >240 | | Cyclophosphamide (20.0mg/ml) | >240 | | Carmustine (3.3mg/ml) | 22.0 | | Thiotepa (10.0mg/ml) | 24.2 | | Paclitaxel (6.0mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0mg/ml) | >240 | | Methotrexate (25.0mg/ml) | >240 | | Vincristine Sulfate (1.0mg/ml) | >24 | "WARNING: Do not use with Carmustine and Thiotepa"
    Device Description
    Not Found
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    K Number
    K202765
    Device Name
    ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2021-05-27

    (248 days)

    Product Code
    KGO, LZC
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Careplus (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: | Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes | |----------------------------------------|------------------------------------------------| | Fluorouracil (50.0mg/ml) | >240 | | Etoposide (20.0mg/ml) | >240 | | Cyclophosphamide (20.0mg/ml) | >240 | | Carmustine (3.3mg/ml) | 13.2 | | Thiotepa (10.0mg/ml) | 12.0 | | Paclitaxel (6.0mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0mg/ml) | >240 | | Methotrexate (25.0mg/ml) | >240 | | Vincristine Sulfate (1.0mg/ml) | >240 | "WARNING: Do not use Carmustine and Thiotepa"
    Device Description
    It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below: | Size | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 | |--------------------|-----|-----|-----|-----|------|-----|-----|-----| | Length, min. mm | 245 | 265 | | | | | | | | Thickness, min. mm | | | | | 0.10 | | | | | Width, ± 6 mm | 70 | 76 | 83 | 89 | 95 | 102 | 108 | 114 |
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    K Number
    K162858
    Device Name
    NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2017-07-24

    (285 days)

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

    Careplus (M) 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 or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
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    K Number
    K152593
    Device Name
    LATEX EXAMINATION GLOVE POWDER FREE
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2016-02-25

    (168 days)

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

    Careplus (M) 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 or finger to prevent contamination between patient and examiner.
    Device Description
    LATEX EXAMINATION GLOVE POWDER FREE
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    K Number
    K142858
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2015-02-09

    (131 days)

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

    Careplus (M) SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination 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.
    Device Description
    POWDER FREE NITRILE EXAMINATION GLOVE, WHITE
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    K Number
    K142862
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2015-01-16

    (107 days)

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

    Careplus (M) 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 or finger to prevent contamination between patient and examiner.
    Device Description
    It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.
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