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510(k) Data Aggregation

    K Number
    K250342
    Device Name
    Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
    Manufacturer
    Encompass Industries Sdn. Bhd.
    Date Cleared
    2025-07-08

    (152 days)

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

    Encompass Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220609
    Device Name
    Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
    Manufacturer
    Encompass Industries Sdn. Bhd.
    Date Cleared
    2022-05-27

    (86 days)

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

    Encompass Industries 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 to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
    Device Description
    The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex.
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    K Number
    K183562
    Device Name
    Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
    Manufacturer
    Encompass Industries Sdn. Bhd.
    Date Cleared
    2019-10-23

    (307 days)

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

    Encompass Industries 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 to prevent contamination between patient and examiner. In addition, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: The following chemotherapy drugs have been tested with the white glove: Cyclophosphamide (Cytoxan) 20.0mg/ml > 240 Doxorubicin Hydrochloride 2.0mg/ml > 240 Etoposide (Toposar) 20.0mg/ml > 240 Fluorouracil 50.0mg/ml > 240 Paclitaxel (Taxol) 6.0mg/ml > 240 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 Carmustine (BCNU) 3.3mg/ml 11.2 Thiotepa (THT) 10.0mg/ml 25.2 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 11.2 minutes 2. Thiotepa: 25.2 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). The following chemotherapy drugs have been tested with the blue glove: Cyclophosphamide (Cytoxan) 20.0mg/ml > 240 Doxorubicin Hydrochloride 2.0mg/ml > 240 Etoposide (Toposar) 20.0mg/ml > 240 Fluorouracil 50.0mg/ml > 240 Paclitaxel (Taxol) 6.0mg/ml > 240 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 Carmustine (BCNU) 3.3mg/ml 10.7 Thiotepa (THT) 10.0mg/ml 21.5 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 10.7 minutes 2. Thiotepa: 21.5 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). The following chemotherapy drugs have been tested with the black glove: Cyclophosphamide (Cytoxan) 20.0mg/ml > 240 Doxorubicin Hydrochloride 2.0mg/ml > 240 Etoposide (Toposar) 20.0mg/ml > 240 Fluorouracil 50.0mg/ml > 240 Paclitaxel (Taxol) 6.0mg/ml > 240 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 Carmustine (BCNU) 3.3mg/ml 11.0 Thiotepa (THT) 10.0mg/ml 11.1 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 11.0 minutes 2. Thiotepa: 11.1 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).
    Device Description
    Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
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