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510(k) Data Aggregation

    K Number
    K231446
    Device Name
    Single-Use Latex Sterile Surgical Gloves (SG100)
    Manufacturer
    Fitone Latex Products Co., Ltd. Guangdong
    Date Cleared
    2023-09-22

    (127 days)

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

    Fitone Latex Products Co., Ltd. Guangdong

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed device, Single-Use Latex Sterile Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
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    K Number
    K221747
    Device Name
    Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
    Manufacturer
    Fitone Latex Products Co., Ltd. Guangdong
    Date Cleared
    2022-12-01

    (168 days)

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

    Fitone Latex Products Co., Ltd. Guangdong

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes. Warning: Please do not use with Carmustine and Thio Tepa.
    Device Description
    The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device. The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
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    K Number
    K222693
    Device Name
    Single-use medical latex examination gloves (LG100)
    Manufacturer
    Fitone Latex Products Co., Ltd. Guangdong
    Date Cleared
    2022-09-24

    (18 days)

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

    Fitone Latex Products Co., Ltd. Guangdong

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use medical latex examination gloves 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 Single-use medical latex examination qloves 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. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal 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 provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.
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    K Number
    K211927
    Device Name
    Nitrile examination gloves
    Manufacturer
    Fitone Latex Products Co., Ltd. Guangdong
    Date Cleared
    2021-10-12

    (112 days)

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

    Fitone Latex Products Co., Ltd. Guangdong

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
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