Search Results

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). It refers to adherence to standards like ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20, and ISO 10993-10, which would inherently include specified sampling plans for testing. However, the exact count of items tested via these standards is not provided.

The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical performance data conducted to support a "substantial equivalence" determination. Given the submitter's address (Houston, TX, USA) and the Beijing agent's address (China), and the product's likely manufacturing location, it's probable the testing was conducted in facilities accustomed to these international standards. The data is retrospective, as it's being submitted for premarket notification.

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

This information is typically not applicable to medical devices like examination gloves. The "ground truth" for these devices is established by adherence to recognized national and international standards (e.g., ASTM, ISO), which specify objective measurement methods and pass/fail criteria. There are no human experts "establishing ground truth" in the way one might for diagnostic imaging interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards. There is no subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic devices, often involving human readers interpreting medical images or data. This is not relevant for examination gloves, which are physical barrier devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The "standalone" performance here refers to the device itself meeting the objective physical, chemical, and biological criteria outlined in the standards, without human interaction influencing the test outcome or interpretation beyond standard lab procedures. The device's performance is assessed purely on its intrinsic properties.

7. The Type of Ground Truth Used

The ground truth used is primarily objective performance standards from recognized bodies:

• ASTM (American Society for Testing and Materials) standards: D5250 (Vinyl Patient Examination Gloves), D5151 (Detection of Holes in Medical Gloves), D6124 (Residual Powder on Medical Gloves).
• 21 CFR 800.20: FDA regulation concerning medical gloves.
• ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and skin sensitization.

The "ground truth" is that if the glove meets the specified numerical/qualitative criteria (e.g., tensile strength ≥11MPa), then it performs as expected for its intended use.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on manufacturing processes and adherence to quality control measures, which are then verified through testing.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device