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A patient examination glove 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. These gloves were tested for use with chemotherapy drugs and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

This document describes the premarket notification (510(k)) for the Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant. The focus of the study is on the non-clinical performance testing of the gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against several standards, including ASTM D6319, ASTM D6124, ASTM D412, ASTM D3767, ASTM D5151, and ASTM D6978, as well as ISO 10993 for biocompatibility.

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

The document primarily describes non-clinical testing.

• For the watertight test, the sample size used was 500 pieces.
• Specific sample sizes for other tests like physical properties, dimensions, residual powder, and biocompatibility are not explicitly stated in quantity, but imply a representative sample was tested to meet the ASTM and ISO standards.
• The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, WRP Asia Pacific Sdn Bhd, based in Malaysia. The studies are prospective as they are testing the new device.

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

This information is not applicable as the document describes non-clinical performance testing of medical gloves against established engineering and biological standards, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the specific test methods and their measurable endpoints (e.g., breakthrough time, tensile strength values).

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical performance testing against objective standards, not subjective assessments requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

This information is not applicable. The device is a medical glove, and no algorithm or AI component is involved.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on established industry standards and regulatory requirements, including:

• ASTM standards (e.g., ASTM D412, D3767, D5151, D6124, D6978) for physical properties, dimensions, watertight integrity, residual powder, and chemical permeation.
• ISO 10993 standards for biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).
  These standards define objective, measurable criteria for the glove's performance.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. Performance is evaluated against pre-defined, physical, and chemical standards.

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

This information is not applicable due to the absence of a training set for this device. The "ground truth" for evaluating the glove's performance is established by the methodologies and specified outcomes mandated by the referenced ASTM and ISO standards.

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A patient examination glove 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.

Powder Free Black Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

This document is a 510(k) Pre-Market Notification for a Powder Free Black Nitrile Examination Glove (K201428) and does not describe a study involving an AI/ML powered device. Instead, it details the substantial equivalence of the new nitrile glove to a predicate device (K153562) based on non-clinical performance and biological safety testing.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, or MRMC studies.

However, I can extract the acceptance criteria and reported performance for the nitrile examination glove based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for the Nitrile Examination Glove):

As there is no AI/ML component to the device described in this document, the following points are not applicable:

2. Sample size used for the test set and the data provenance: Not applicable. (Performance claims are based on physical and biological tests of the glove material, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (Ground truth not established in the context of an AI/ML test set.)
4. Adjudication method for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML. For the glove, the "ground truth" or reference for performance is established by ASTM standards and ISO biological evaluation guidelines.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

A Powder-free pateint examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Black Nitrile Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA for Powder Free Black Nitrile Examination Gloves. It primarily discusses the regulatory classification and general controls for the device and confirms its substantial equivalence to a predicate device.

It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or information about AI/ML models.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device