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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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.

This document describes the safety and effectiveness summary for Cardinal Health's Nitrile Powder-Free Examination Gloves with Coating, submitted under 510(k) number K032444.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for this device are based on meeting safety and performance standards for examination gloves, particularly with added protection against chemotherapy drugs. The reported performance demonstrates compliance with these standards.

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

The document does not specify the exact sample sizes used for each of the tests (e.g., number of gloves tested for tensile strength or barrier defects, number of animals for skin irritation). The data provenance is not explicitly stated as country of origin, but it is implied to be from Cardinal Health's testing procedures, conducted prior to the 510(k) submission date of July 25, 2003, hence, retrospective in relation to the submission.

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

This information is not provided in the summary. The tests performed are standardized material and biological safety tests (ASTM, CFR), which rely on established protocols rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This is not applicable for the types of tests described. The tests are based on objective measurements and established pass/fail criteria from regulatory standards and ASTM methods, not on expert adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. The device is an examination glove, and the testing focuses on its material properties, barrier integrity, and biological safety, not on diagnostic accuracy requiring human reader interpretation.

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

This is not applicable. The device is a physical product (a glove), not an algorithm or AI software. Therefore, there is no concept of "standalone performance" in the context of an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on:

• Established ASTM Standards: For mechanical properties like tensile strength and barrier integrity.
• Regulatory Requirements: As stipulated by 21 CFR for barrier defects.
• Biological Safety Protocols: For primary skin irritation and guinea pig maximization, which determine the absence of irritation or sensitization.
• Standardized Chemotherapy Drug Permeation Testing: Using ASTM F739-99a.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set. The manufacturing process itself is expected to produce consistent products that adhere to the established quality and performance standards.

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

This is not applicable as there is no "training set" in the context of developing this medical device. The "ground truth" for ensuring quality during manufacturing would be established through ongoing quality control processes that verify the product meets the specifications outlined by the ASTM and CFR standards, as detailed in point 7.

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