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A patient examination glove is a disposable device 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, white colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.

The gloves are designed and manufactured per ASTM D6319-10 standard and tested for use with chemotherapy drugs per ASTM D6978-05 (reapproved 2013).

The provided text describes the regulatory submission for the "Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)" and the testing conducted to support its claims, specifically its resistance to chemotherapy drugs.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the chemotherapy drug resistance are the breakthrough times for various chemotherapy drugs, as tested per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the minimum breakthrough time for each drug.

Other acceptance criteria are derived from ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application, including:

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

• Sample Size: The document does not explicitly state the sample size used for each individual chemotherapy drug permeation test. However, the testing was conducted per ASTM D6978-05 (Reapproved 2013). This standard outlines procedures for testing, and typically specifies minimum sample sizes or replicates required to ensure statistically significant results. Without access to the specific test report, the exact number of gloves tested for each drug cannot be determined from this summary.
• Data Provenance: The testing was conducted in accordance with recognized ASTM (American Society for Testing and Materials) standards. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, but as it's a 510(k) submission, it would be prospective testing performed specifically for this submission.

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

This information is not applicable to this type of device and testing. The "ground truth" for the device's performance regarding chemotherapy drug permeation is established through a standardized, objective laboratory test (ASTM D6978-05). It does not involve human expert interpretation of data in the way medical imaging or diagnostic algorithms would. The ASTM standard itself defines the methodology and interpretation of results.

4. Adjudication Method for the Test Set:

This is not applicable. The testing involves a direct measurement of breakthrough time using analytical methods, not subjective assessment requiring adjudication among multiple human observers.

5. 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:

This is not applicable. This device is a physical examination glove, not an AI-powered diagnostic system. Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical glove, not an algorithm or AI system. The performance testing described is standalone for the glove itself, meaning its physical properties are tested without human interaction as part of the measurement process (e.g., a person wearing the glove and interacting with chemotherapy drugs). The test determines the intrinsic resistance of the material.

7. The Type of Ground Truth Used:

The ground truth used is based on standardized laboratory measurements and physical property tests. Specifically:

• Permeation by Chemotherapy Drugs: Determined by the "breakthrough time" measured according to ASTM D6978-05 (Reapproved 2013). This is an objective, quantitative measurement using analytical instrumentation.
• Physical Properties (e.g., tensile strength, elongation, freedom from holes, dimensions, residual powder): Determined by standardized test methods outlined in ASTM D6319-10 and ASTM D5151-06. These are also objective, quantitative measurements.
• Biocompatibility: Determined by standardized tests for primary skin irritation and dermal sensitization according to ISO 10993-10. These are biological tests that produce objective results, often interpreted by qualified toxicologists/biocompatibility specialists.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical product (a glove), not a machine learning model. Therefore, there is no "training set." The performance is inherent to the manufactured product's material and design, tested against established standards.

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

This is not applicable as there is no training set for this type of device.

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