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    K Number
    K220353
    Device Name
    Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
    Manufacturer
    Niujian Technology Co., Ltd
    Date Cleared
    2022-03-31

    (51 days)

    Product Code
    LZC,LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes:
    Cisplatin, 1.0 mg/ml (1,000 ppm) >240 min.
    Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min.
    Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min.
    Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min.
    Etoposide, 20.0 mg/ml (20,000 ppm) >240 min.
    Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min.
    Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min.
    Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min.
    ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min
    Please note that the following drug has low permeation times of less than 60 minutes:
    Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes
    ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes
    WARNING: Do not use Carmustine and Thiotepa

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs. It's a Class I reserved device and, as such, the provided information does not describe an AI/ML device but rather a physical device (gloves). Therefore, many of the requested criteria regarding AI/ML study design are not applicable.

    Here's the relevant information that can be extracted from the provided text, focusing on the device's performance regarding chemotherapy drug resistance:

    Acceptance Criteria and Device Performance for Chemotherapy Drug Permeation

    The acceptance criteria are implicitly defined by the test results indicating "NO breakthrough detected up to 240 minutes" for most listed chemotherapy drugs, in accordance with ASTM D6978-05(2019). For drugs with breakthrough times below 240 minutes, those times are reported, along with a warning for those under 60 minutes.

    Acceptance Criteria (Target Breakthrough Time per ASTM D6978-05(2019))Reported Device Performance (Minimum Breakthrough Detection Time)
    No breakthrough for at least 240 minutesCisplatin, 1.0 mg/ml (1,000 ppm): >240 min.
    No breakthrough for at least 240 minutesCyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm): >240 min.
    No breakthrough for at least 240 minutesDacarbazine, 10.0 mg/ml (10,000 ppm): >240 min.
    No breakthrough for at least 240 minutesDoxorubicin HCI, 2.0 mg/ml (2,000 ppm): >240 min.
    No breakthrough for at least 240 minutesEtoposide, 20.0 mg/ml (20,000 ppm): >240 min.
    No breakthrough for at least 240 minutesFluorouracil, 50.0 mg/ml (50,000 ppm): >240 min.
    No breakthrough for at least 240 minutesPaclitaxel, 6.0 mg/ml (6,000 ppm): >240 min.
    Breakthrough time reportedCarmustine (BCNU) 3.3 mg/ml (3,300 ppm): 38.7 min.
    Breakthrough time reportedThioTepa 10.0 mg/ml (10,000 ppm): 56.9 min.

    Important Note: The document explicitly warns against using the gloves with Carmustine and ThioTepa due to their low permeation times (less than 60 minutes).

    The following points are not applicable to this device as it is a physical medical device (examination gloves) and not an AI/ML powered diagnostic or therapeutic device. The requested information pertains to studies typically conducted for AI/ML performance evaluation.

    1. Sample size used for the test set and the data provenance: Not applicable. This refers to physical material testing, not data analysis.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to a standard like ASTM D6978-05(2019) involves laboratory procedures, not expert consensus on medical images or diagnoses.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used here is the physical barrier performance of the glove against specific chemical permeation, determined according to the standardized laboratory methods described in ASTM D6978-05(2019). This is a scientific, objective measurement, not based on expert consensus or clinical outcomes for diagnosis.
    7. The sample size for the training set: Not applicable. This concept is for AI/ML models.
    8. How the ground truth for the training set was established: Not applicable.
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