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The Non-sterile Powder Free Black Nitrile Examination Gloves with Cherry Flavor, 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.

Doves I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00a (2005) Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the acceptance criteria and the study proving the device meets those criteria for Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor.

It's important to note that this is a premarket notification (510(k)) for a Class I medical device (patient examination glove). The "study" here refers to demonstrating compliance with established performance standards and biocompatibility testing, rather than a clinical trial with human subjects in the way one might think of for more complex medical devices or pharmaceuticals.

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 sizes used for each specific test (e.g., number of gloves tested for water leak, number of residual powder tests). However, for standards like ISO 2859-1, specific sampling plans (sample sizes and acceptable quality limits - AQLs) are defined within the standard itself for batch testing.

The data provenance is from Thailand (SGMP Company Limited is in Thailand). The data is retrospective in the sense that the testing was conducted prior to submission for regulatory clearance.

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

This type of submission for examination gloves does not typically involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). Instead, the "ground truth" is adherence to the performance specifications defined by the ASTM and ISO standards themselves. The "experts" involved would be the qualified laboratory personnel performing the standardized tests according to the written protocol of each standard. Their qualifications would be in laboratory practices, quality control, and the specific test methodologies. The number of such personnel is not specified.

4. Adjudication Method

Not applicable for this type of device and testing. Test results against established standards do not typically involve adjudication among multiple human readers. Outcomes are binary: pass/fail the standard's defined limits.

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

Not applicable. This is not the type of device where MRMC studies are performed. MRMC studies are typically for diagnostic imaging devices where human interpretation is a key component.

6. Standalone Performance Study

Yes, in a sense. The compliance with ASTM and ISO standards demonstrates the standalone performance of the device (the glove itself, without a human "in-the-loop" in the way an AI diagnostic tool would have). The biocompatibility testing also evaluates the standalone biological performance of the glove material.

7. Type of Ground Truth Used

The ground truth used is primarily performance specifications defined by internationally recognized standards (ASTM and ISO), along with biocompatibility testing results.

• ASTM D6319-00a(2005): Defines physical properties (e.g., tensile strength, elongation, force at break) for nitrile examination gloves.
• ISO 2859-1 / ASTM D5151-06: Specifies acceptable levels of pinholes in gloves.
• ASTM D6124-06: Specifies limits for residual powder.
• Biocompatibility Testing: Involves a series of tests (often based on ISO 10993 standards, though not explicitly stated here for gloves) to assess the biological response to the device, conducted on animals (White Rabbits and Guinea Pigs).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a "training set." The testing performed is to demonstrate compliance of manufactured batches with established performance standards.

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

Not applicable, as there is no training set for this device.

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