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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.

This document describes the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by SHANDONG JUNFENG INDUSTRIES CO., LTD.

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 within the ASTM standards or the biocompatibility tests. However, the tests performed (e.g., freedom from pinholes, powder residual, primary skin irritation, dermal sensitization) imply that samples of the gloves were rigorously tested according to the specified international and national standards.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective," but the testing was conducted to meet established standards like ASTM and ISO, which are internationally recognized. The testing would have been prospective in nature, as the device was manufactured and then tested against these criteria to demonstrate compliance.

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

This section is not applicable in the context of device performance testing against established standards for patient examination gloves. The "ground truth" here is defined by the objective metrics and thresholds set out in the ASTM and ISO standards themselves, not by expert consensus on qualitative observations. The product simply had to "meet" the quantitative or qualitative pass/fail criteria of these standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple experts. This is not relevant for the objective performance testing described for these gloves. The device performance was evaluated directly against the quantitative and qualitative requirements of the listed standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. This is not applicable to patient examination gloves, which are physical barrier devices.

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

No, a standalone (algorithm-only) performance study was not done. This concept is applicable to AI/ML software devices. The device in question is a physical medical device (gloves) and its performance is evaluated through material and physical property tests, not algorithmic performance.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises:

• Objective Standards: Defined by international and national consensus standards such as ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10. These standards specify precise methodologies for testing and define quantifiable pass/fail criteria (e.g., maximum allowable pinholes, maximum powder residual, specific methods for biocompatibility testing).
• Laboratory Testing Results: The "Meets" or "Passes" reported for each characteristic directly reflects the results of laboratory tests conducted in accordance with these objective standards.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI. The device is a physical product (gloves), not an AI algorithm. Therefore, the concept of a training set is not applicable. The manufacturer produces the gloves, and then tested samples from production lots against the outlined standards.

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

As explained in point 8, the concept of a "training set" is not applicable to this device. Therefore, no ground truth was established for a training set. The "ground truth" for the device's acceptable performance is derived from the established and publicly available standards it must meet.

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