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Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10

This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, 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 provided text does not explicitly state the sample sizes used for the various tests.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin of the data. However, the manufacturer is from China (Tangshan Zhonghong Pulin Plastic Co., Ltd., China), suggesting the testing might have been conducted there or through certified labs.

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

This type of information is not applicable to this device. The testing involves adherence to established technical standards (ASTM, CFR, ISO) for physical properties and biocompatibility, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is defined by the objective pass/fail criteria of these standards.

4. Adjudication Method for the Test Set

This information is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical events, not for standardized physical and chemical property testing of a product like examination gloves. The testing follows predefined methodologies within the cited standards.

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

An MRMC comparative effectiveness study was not conducted and is not relevant for this device. Such studies are typically performed for diagnostic or screening devices where human readers interpret results, often with AI assistance. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.

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

A standalone performance study was not conducted and is not relevant for this device. This concept applies to AI/software algorithms. The "performance" of these gloves is their intrinsic material and functional characteristics, which are tested through laboratory methods.

7. Type of Ground Truth Used

The ground truth used for this device is based on established technical standards and regulatory requirements. Specifically:

• Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): Defined by the specified ASTM standards (D 6139-10, D 5250-06, D6124-06) and FDA regulation (21 CFR 800.20). The "ground truth" is whether the glove's measured properties fall within the acceptable ranges or thresholds defined by these standards.
• Biocompatibility: Defined by the results of specific animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) which have clear "Pass" criteria for demonstrating absence of irritation or sensitization. The ISO 10993-10 standard would outline the methodology and criteria for these tests.

8. Sample Size for the Training Set

This information is not applicable to this device. The concept of a "training set" belongs to machine learning and AI algorithms. The manufacturing process of gloves does not involve a training set in this context. The "training" for manufacturing would be the established quality control and production procedures.

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

This information is not applicable for the same reasons as point 8.

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