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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 POLY-VINYL EXAMINATION GLOVES, COLOR: WHITE

The document describes the summary of a 510(k) premarket notification for "Powder-Free Poly-Vinyl Examination Gloves, Color: White" by GLORMED INTERNATIONAL, INC. This device is classified as a Class I medical device (80LYZ) and is intended for medical purposes to prevent contamination between patient and examiner.

The submission focuses on demonstrating substantial equivalence to previously marketed devices (K002340 and K992979) rather than presenting a detailed de novo device study. Therefore, the information regarding acceptance criteria, study details, and specific performance metrics for this particular device is limited to compliance with established standards.

Here's an breakdown based on the provided text:

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 size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to have been conducted to demonstrate compliance with the listed ASTM and IEST-RP standards, which would typically involve testing a sample of the manufactured gloves.

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

This information is not applicable and not provided in the document. The device is a patient examination glove, and its performance is evaluated against material and biocompatibility standards, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance is measured against predefined technical and biological standards, not through adjudication of expert opinions.

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

No MRMC comparative effectiveness study was conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging software) where human readers' performance is influenced by the device. For examination gloves, the focus is on material properties and safety.

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

This information is not applicable and not provided. The device is a physical product (gloves), not an algorithm or software. Its performance is inherent in its physical and chemical properties.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and tests for physical properties (e.g., tear resistance, tensile strength – implied by ASTM standards mentioned) and biological safety (biocompatibility tests).

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is not a machine learning model that requires a training set.

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

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

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