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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 (non-colored) that meets all of the requirements of ASTM standard D 5250-004.

Acceptance Criteria and Study for Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves

This document summarizes the acceptance criteria and the study conducted to demonstrate that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves meet these criteria, as described in the provided 510(k) summary (K032783).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample sizes used for the individual tests (e.g., number of gloves tested for dimensions, physical properties, or pinholes).

The data provenance is implicit: the tests were conducted by the manufacturer, Zibo Blue Sail Chemical Co., Ltd., presumably in P.R. China, to demonstrate compliance with the specified ASTM standards and FDA regulations. The studies appear to be retrospective in nature, as they involve testing a manufactured product against established standards.

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

Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical parameters defined by established industry standards (ASTM) and federal regulations (CFR). There is no mention of human experts being used to establish a "ground truth" for the performance of the gloves beyond interpreting the results of standardized tests.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are based on objective measurements against defined standard limits, an adjudication method for conflicting expert opinions is not relevant. The pass/fail criteria are directly derived from the standards.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or interpretive medical devices where human readers (e.g., radiologists) interpret images or data. Patient examination gloves are a physical barrier device, and their effectiveness is assessed through physical and biocompatibility testing, not through human interpretation of medical data.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a medical glove, not an algorithm or software. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply. The performance evaluation focuses on the physical and chemical characteristics of the glove itself.

7. Type of Ground Truth Used

The ground truth used for evaluating this device is based on objective, quantitative standards and regulatory requirements. Specifically:

• ASTM standards (D 5250-00e4 and presumably D6124-01): These standards define the acceptable ranges for physical properties (dimensions, tensile strength, elongation, puncture resistance) and powder amount.
• 21 CFR 800.20: This regulation defines the acceptable quality level (AQL) for freedom from pinholes (water leak test).
• ISO 10993-10: This international standard covers biological evaluation of medical devices, specifically for irritation and sensitization.

Essentially, the "ground truth" is defined by the pass/fail criteria specified within these published standards and regulations.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (medical glove), not an AI/ML algorithm or system that requires a "training set" in the context of machine learning. The manufacturing process is subject to quality control, but there is no "training set" of data for an algorithm.

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

Not applicable. As established in point 8, there is no "training set" for this device. The manufacturing and testing processes follow established quality management systems and standard operating procedures to ensure consistent product quality, but this is distinct from establishing ground truth for machine learning training.

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