LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192241
    Device Name
    Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    O & M Haylard, Inc.
    Date Cleared
    2020-03-13

    (207 days)

    Product Code
    LZA,LZC,QDO
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K102032
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05:
    Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
    Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
    Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
    Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
    Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
    Busulfan (6 mg/ml) No breakthrough up to 240 minutes
    Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
    Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes
    Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes
    Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
    Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
    Cladribine (1 0 mg/ml) No breakthrough up to 240 minutes
    Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
    Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
    Cytovene (10 mg/ml) No breakthrough up to 240 minutes
    Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
    Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
    Decitabine (5 mg/ml) No breakthrough up to 240 minutes
    Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
    Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
    Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
    Etoposide (20 mg/ml) No breakthrough up to 240 minutes
    Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
    Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
    Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
    Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
    Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
    Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
    Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
    Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
    Melphalan (5 mg/ml) No breakthrough up to 240 minutes
    Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
    Mitomycin-C (0 5 mg/ml) No breakthrough up to 240 minutes
    Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
    Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
    Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
    Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
    Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
    Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
    Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
    Retrovir (10 mg/ml) No breakthrough up to 240 minutes
    Rituximab (10 mg/ml) No breakthrough up to 240 minutes
    Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
    Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
    ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes
    Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
    Triclosan (1 mg/ml) No breakthrough up to 240 minutes
    Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes
    Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
    Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
    Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
    Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
    Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes

    Device Description

    Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves.

    AI/ML Overview

    This document is a 510(k) premarket notification for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. It describes the device's technical characteristics and performance data compared to a predicate device.

    The acceptance criteria and study that proves the device meets them are related to the physical and chemical properties of the gloves and their barrier efficacy against certain hazardous substances, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone algorithm performance, ground truth establishment for training set) are not applicable to this type of medical device submission.

    However, I can extract the relevant information regarding the acceptance criteria and the performance studies that were conducted to support the substantial equivalence claim.

    Acceptance Criteria and Reported Device Performance

    The core of the acceptance criteria for these exam gloves is based on established ASTM and ISO standards for medical gloves, focusing on their physical integrity, powder content, biocompatibility, and resistance to permeation by chemotherapy drugs and fentanyl citrate.

    1. Table of Acceptance Criteria and the Reported Device Performance:

    TestStandardAcceptance CriteriaReported Device Performance (Subject Device)
    DimensionsASTM D6319Length $\geq$ 230mm; Palm width (size-specific range); Finger/Palm Thickness $\geq$ 0.050 mm; Cuff Thickness 0.10-0.13 mm (Halyard)The physical dimensions of the subject device are within the limits of the standard.
    Physical Properties (Tensile Strength & Ultimate Elongation)ASTM D6319Before Aging: Tensile Strength $\geq$ 14 MPa, Ultimate elongation $\geq$ 500%After Aging: Tensile Strength $\geq$ 14 MPa, Ultimate elongation $\geq$ 400%Physical properties of the subject device meet the requirements for tensile strength and elongation in the standard.
    Freedom from PinholesASTM D6319, ASTM D5151AQL 2.5% (Acceptable Quality Level for leakage)No leakageTesting of the subject device shows it meets the AQL requirement in the standards for leakage.
    Powder-FreeASTM D6124, ASTM D6319$\le$ 2 mg / glove (maximum powder per glove)Residual powder on the subject device is within the powder-free limits prescribed in the standards (average of 0.4 mg/glove).
    ISO Indirect Irritation StudyISO 10993, Part 10Primary Irritation Index $\le$ 2.0Under the conditions of the study, the device is not an irritant.
    ISO Systemic Toxicity StudyISO 10993, Part 11No animals treated with test extracts exhibit greater reaction than control animalsNo evidence of systemic toxicity.
    ISO Dermal SensitizationISO 10993, Part 10Grade < 1Under the conditions of the study, the device is not a sensitizer.
    Resistance to Permeation by Chemotherapy DrugsASTM D6978-05No breakthrough was detected for up to 240 minutes for all listed chemotherapy drugs (with specific breakthrough time noted for Carmustine)Performance for subject device: 51 chemotherapy drugs showed no breakthrough for up to 240 minutes, except for Carmustine which had permeation at 169.8 minutes. This is documented against the predicate device's performance where Carmustine permeated at 48.6 minutes. This indicates better performance for the subject device regarding Carmustine.
    Resistance to Permeation by Fentanyl Citrate InjectionASTM D6978-05No breakthrough up to 240 minutesNo signs of breakthrough after 4 hours for Fentanyl Citrate Injection (100 mcg/2ml). This was a new claim not tested for the predicate device.
    Clinical Study (for Type IV allergic contact sensitization)Jordan-King modification of the Draize test (as recommended by FDA)(Implied: Device is non-irritating and shows no clinical evidence of residual chemical additives that may induce Type IV allergy)A 204 subject study was completed. Under the conditions of the study, the subject device was non-irritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects.

    2. Sample Size for the Test Set and Data Provenance:

    • Non-Clinical Tests: For tests based on ASTM standards (e.g., D6319, D5151, D6124, D6978), the sample sizes are determined by the specific standard's testing methodology, often involving a certain number of gloves per batch or condition to achieve statistical significance (e.g., AQL for pinholes). The document does not explicitly state these per-test sample sizes but confirms adherence to the standards.
    • Biocompatibility Tests (ISO 10993): These involve animal testing, with sample sizes determined by the ISO standards for systemic toxicity, irritation, and sensitization. The document doesn't provide the exact number of animals but states the acceptance criteria were met.
    • Clinical Study (Type IV Allergic Contact Sensitization): A 204 subject study was completed.
    • Data Provenance: The document does not specify the country of origin for the non-clinical or clinical test data. Given it's an FDA submission for a US-based company (O & M Halyard, Inc., Alpharetta, GA), it's highly probable the testing was conducted in the US or in labs compliant with US regulatory requirements. The studies implicitly appear to be prospective studies conducted specifically for this submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    • N/A. The ground truth for this device is based on objective laboratory measurements and standardized test procedures (e.g., chemical breakthrough, physical dimensions, tensile strength, biological responses in animal/human models as per ISO/ASTM standards). It does not involve expert consensus on interpreting images or clinical cases like an AI/ML diagnostic device would.

    4. Adjudication Method for the Test Set:

    • N/A. Adjudication is not relevant to the nature of these physical and chemical performance tests.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • N/A. This is a physical product, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.

    6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

    • N/A. This is a physical product.

    7. The Type of Ground Truth Used:

    • The ground truth for this device's performance is established through objective, standardized laboratory measurements and biological responses to samples of the device, as defined by ASTM and ISO protocols. This includes:
      • Quantitative measurements (e.g., length, thickness, tensile strength, residual powder, breakthrough time for chemicals).
      • Qualitative observations of biological reactions in animal models (for toxicity, irritation, sensitization).
      • Clinical observations in human subjects (for allergic sensitization).

    8. The Sample Size for the Training Set:

    • N/A. There is no "training set" in the context of this traditional medical device. The device's manufacturing process and material composition are developed and optimized through R&D, not trained on data in a machine learning sense.

    9. How the Ground Truth for the Training Set Was Established:

    • N/A. As there is no training set for this type of device, this question is not applicable. The device's design and manufacturing rely on established engineering principles and material science, validated through the non-clinical and clinical testing described.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1