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Powdered 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.

powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.

The provided document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)". This is a Class I medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information details the acceptance criteria and the methods used to prove the device meets these criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Meets" or "Passes" for most criteria, indicating successful adherence to the specified standards or thresholds. For powder amount, a specific value (<10mg/dm2) is given.

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

The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device. Instead, the device is a physical product (gloves) and its performance is evaluated against established physical and chemical standards. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) for data in the typical sense of AI/machine learning studies is not directly applicable here.

For the physical and chemical property tests, it's highly probable that samples from manufacturing batches were used. However, the exact sample sizes for each test (e.g., how many gloves were tested for pinholes, how many for dimensions, how many animals for biocompatibility) are not provided in this summary.

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

This question is not applicable to this device and study. The "ground truth" for the performance of these gloves is established by objective, standardized tests and measurements against published ASTM and CFR standards, not by expert consensus on clinical findings or images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The performance of these gloves is determined through objective laboratory tests.

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 or interpretive AI systems where the performance of human readers with and without AI assistance is compared. This device is a patient examination glove, not an AI diagnostic tool.

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

No, a standalone performance study was not done. This concept applies to AI algorithms and is not relevant for a physical medical device like examination gloves.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, predefined standards and test methods. Specifically:

• ASTM standard D 5250-00e4: For dimensions, physical properties, and powder amount. This standard outlines measurable specifications and test procedures.
• 21 CFR 800.20: For freedom from pinholes. This regulation defines the acceptable quality level (AQL) for pinholes and the test method (water leak test).
• ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization). This standard specifies the in-vivo biological evaluation tests to assess potential adverse reactions.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for this device, as it is a physical product, not an AI model requiring data for training.

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

This question is not applicable, as there is no training set.

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