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510(k) Data Aggregation

    K Number
    K223859
    Device Name
    Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
    Manufacturer
    Date Cleared
    2023-02-13

    (52 days)

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

    Rhino Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 14.2 Cisplatin (1.0 mg/mL 1,000 ppm) > 240 Cyclophosphamide (Cytoxan) (20 mg/mL 20,000 ppm) > 240 Dacarbazine (10 mg/mL 10,000 ppm) > 240 Doxorubicin Hydrochloride (2.0 mg/mL 2,000 ppm) > 240 Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) > 240 Flurouracil (50.0 mg/mL 50,000 ppm) > 240 Paclitaxel (Taxol) (6.0 mg/mL 6,000 ppm) > 240 Thiotepa (10.0 mg/mL 10,000 ppm) 43.2 Fentanyl Tested as Follows: Fentanyl Citrate Injection (100 mcg/2mL) > 240 Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
    Device Description
    Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in three sizes, extra small, small, and extra large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows: Glove Size | Part Numbers ---|--- XS | RHI-UNB5XS100BX1 S | RHI-UNB5S100BX1 XL | RHI-UNB5XL100BX1
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    K Number
    K221082
    Device Name
    Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
    Manufacturer
    Date Cleared
    2022-11-30

    (231 days)

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

    Rhino Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: | Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time | |-------------------------------------------------------------------------|-------------------------|-------------------------------------| | Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 | | Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 | | Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 | | Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 | | Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 | | Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 | | Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 | | Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 | | Thiotepa | (10.0 mg/mL 10,000 ppm) | 43.2 | | Fentanyl Tested as Follows:<br>Fentanyl Citrate Injection (100 mcg/2mL) | | > 240 | Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
    Device Description
    Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in two sizes, medium and large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows: | Glove Size | Part Numbers | |------------|-----------------| | M | RHI-UNB5M100BX1 | | L | RHI-UNB5L100BX1 |
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