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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?
    Product Code :

    LYY

    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
    K240266
    Device Name
    Latex Examination Glove Powder Free (Ocean Blue and Natural White)
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2024-09-09

    (222 days)

    Product Code
    LYY, LZC, OPJ, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs and permeation times are as follows: Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine HC1 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin HC1 5 mg/mL, >240 minutes Docetaxel 20 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin HCl 1 mg/mL, >240 minutes lfosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine HC1 1 mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 3.7 minutes Trisenox 1 mg/mL . >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes WARNING: Not for use with Carmustine or Thiotepa.
    Device Description
    This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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    K Number
    K230573
    Device Name
    Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
    Manufacturer
    Kossan International Sdn Bhd
    Date Cleared
    2023-06-13

    (104 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    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 to prevent contamination between patient and examiner.
    Device Description
    Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
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    K Number
    K223298
    Device Name
    Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
    Manufacturer
    Shandong Intco Medical Products Co, Ltd.
    Date Cleared
    2023-02-22

    (118 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
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    K Number
    K222612
    Device Name
    Powder-Free Latex examination gloves
    Manufacturer
    Guangdong Kingfa Sci.&Tech. Co., Ltd.
    Date Cleared
    2022-11-25

    (87 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. 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 proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
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    K Number
    K221667
    Device Name
    Non Sterile Powder Free Latex Examination Glove
    Manufacturer
    New Era Medicare Sdn. Bhd.
    Date Cleared
    2022-10-28

    (142 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Non Sterile Powder Free Latex Examination Gloves
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    K Number
    K222348
    Device Name
    JR MEDIC
    Manufacturer
    JR Engineering & Medical Technologies (M) SDN.BHD.
    Date Cleared
    2022-10-27

    (85 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.
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    K Number
    K221374
    Device Name
    Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Cleared
    2022-10-26

    (167 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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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?
    Product Code :

    LYY

    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
    K221648
    Device Name
    Iconic Latex Glove
    Manufacturer
    Iconic medicare sdn bhd
    Date Cleared
    2022-08-25

    (79 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This non-powdered 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.
    Device Description
    The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.
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