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Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" and its substantial equivalence to a predicate device. The information details the acceptance criteria and the studies conducted to demonstrate that the device meets these criteria.

Here's a breakdown of the requested information:

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

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

The document does not specify the exact sample sizes used for the test sets for each characteristic. It broadly states that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10," implying that the testing was conducted according to the guidelines and sample size recommendations of these standards.

The data provenance is retrospective, as the studies were conducted by the manufacturer to demonstrate compliance with existing standards for market clearance. The country of origin of the data would be China, given the submitter's address.

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

This information is not provided in the document. For physical and chemical tests of gloves, "ground truth" is typically established by objective measurements and adherence to specified standard limits, rather than expert consensus on subjective interpretations. For biocompatibility, animal testing protocols are followed.

4. Adjudication Method for the Test Set:

This information is not applicable for the type of testing described (physical, chemical, and basic biocompatibility of gloves). Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., medical imaging, clinical assessment) where there's potential for disagreement among experts.

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

An MRMC comparative effectiveness study was not performed and is not relevant for this device. This type of study investigates the impact of an AI system on human reader performance, which doesn't apply to examination gloves.

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

A standalone study was performed in the sense that the device itself was subjected to various tests (dimension, physical properties, freedom from pinholes, powder residual, biocompatibility) to assess its intrinsic performance against established standards, without requiring human interaction beyond the execution of the tests. The device is not an algorithm, so the "algorithm only" phrasing is not strictly applicable.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Standard Specifications: For most characteristics (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the ground truth is defined by the quantitative and qualitative requirements outlined in the cited ASTM standards (D 5250-06, D6124-06) and FDA regulations (21 CFR 800.20).
• Biological Response Criteria: For Biocompatibility, the ground truth is established by the accepted biological response criteria in the animal models used for Primary Skin Irritation and Dermal Sensitization tests, as guided by ISO10993-10.

8. Sample Size for the Training Set:

This information is not applicable as the device is a physical product (gloves) and not an AI/machine learning algorithm requiring a training set.

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

This information is not applicable as the device does not involve an AI/machine learning algorithm with a training set.

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