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510(k) Data Aggregation

    K Number
    K250069
    Device Name
    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2025-04-29

    (109 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
    Device Description
    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
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    K Number
    K240269
    Device Name
    Nitrile Powder Free Examination Gloves Biodegradable (Green)
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2024-10-25

    (268 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
    Device Description
    Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.
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    K Number
    K241528
    Device Name
    Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2024-08-06

    (68 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
    Device Description
    Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K192954
    Device Name
    Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2020-06-19

    (242 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K200181
    Device Name
    Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2020-04-15

    (82 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows: Cisplatin 1.0 mg/ml >= 240 Cyclophosphamide (Cytoxan) 20 mg/ml >= 240 Dacarbazine (DTIC) 10.0 mg/ml >= 240 Doxorubicin Hydrochloride 2.0 mg/ml >= 240 Etoposide (Toposar) 20.0 mg/ml >= 240 Fluorouracil 50.0 mg/ml >= 240 Paclitaxel (Taxol) 6.0 mg/ml >= 240 *Carmustine (BCNU) 3.3mg.ml 54.1 (minutes) *Thiotepa 10.0 mg/ml 6.0 (minutes) *Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa. Tested Fentanyl Citrate is as follows: Fentanyl Citrate Injection 100.0 mcg/2ml Average Breakthrough Detection Time (minutes) >= 240
    Device Description
    Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K190080
    Device Name
    Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2019-06-27

    (162 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
    Device Description
    Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K180476
    Device Name
    Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2018-05-15

    (82 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows: | | Average Breakthrough Detection Time (minutes) | |-------------------------------------|-----------------------------------------------| | Cisplatin 1.0 mg/ml | ≥ 240 | | Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 | | Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 | | Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 | | Etoposide (Toposar) 20.0 mg/ml | ≥ 240 | | Fluorouracil 50.0 mg/ml | ≥ 240 | | Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 | Please note that the following drugs have extremely low permeation time for *Carmustine (BCNU) 3.3mg.ml - 23.4 (mins) *Thiotepa 10.0 mg/ml - 16.2 (mins)
    Device Description
    The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.
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    K Number
    K171541
    Device Name
    Powder Free Nitrile Examination Gloves (Orange)
    Manufacturer
    Comfort Rubber Gloves Industries Sdn. Bhd.
    Date Cleared
    2017-09-20

    (117 days)

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

    Comfort Rubber Gloves Industries Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
    Device Description
    The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
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