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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Sri Trang Gloves (Thailand) Public Company Limited

    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
    K232614
    Device Name
    Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2024-05-13

    (259 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    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 are as follows: Carmustine (BCNU) 3.3 mg/mL, 23 minutes Cisplatin 1.0 mg/mL. >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 68.2 minutes Vincristine Sulfate 1.0 mg/mL, >240 minutes WARNING: Not for use with Carmustine and Thiotepa. Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
    Device Description
    Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Violet Blue)
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    K Number
    K221165
    Device Name
    Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2022-11-20

    (212 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
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    K Number
    K212482
    Device Name
    Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2022-08-09

    (365 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    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. CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.
    Device Description
    Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
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    K Number
    K212309
    Device Name
    Non-sterile, Powder-Free Latex Examination Glove
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2022-04-08

    (259 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    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. This glove contains 50 micrograms or less of total water extractable protein per gram. CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions
    Device Description
    Non-sterile, Powder-Free Latex Examination Glove
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    K Number
    K200539
    Device Name
    Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2020-04-09

    (37 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    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: Carmustine (BCNU) 3.3 mg/mL, 11.6 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 36.2 minutes Vincristine Sulfate 1.0 mg/mL. >240 minutes WARNING: Not for use with Carmustine and Thiotepa. Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
    Device Description
    Non-sterile, Powder-Pree Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
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    K Number
    K193581
    Device Name
    Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
    Manufacturer
    Sri Trang Gloves (Thailand) Public Company Limited
    Date Cleared
    2020-03-20

    (88 days)

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

    Sri Trang Gloves (Thailand) Public Company Limited

    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, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (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 1 mg/mL, >240 minutes Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 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, 27.9 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
    Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
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