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

Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document describes the safety and effectiveness summary for Non-Sterile, Powder Free Black Nitrile Examination Gloves, which are classified as a Class I medical device. The document focuses on demonstrating substantial equivalence to a predicate device (K000868) by meeting established industry standards for examination gloves.

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

• Tensile Strength
• Elongation
• Dimensions (Length, Palm Width, Finger Thickness) |
  | 1SO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. | Detection of holes in medical gloves | Meets the requirements of ISO 2859-1 and/or ASTM D5151-06 (Water Leak Test) | Water Leak Test (specifics of sample size/method not detailed beyond standard reference) |
  | ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. | Measurement of residual powder | Meets the requirements of ASTM D6124-06 (Residual Powder Test) | Residual Powder Test (specifics of sample size/method not detailed beyond standard reference) |
  | Biocompatibility Testing | Biocompatibility on White rabbits and Guinea pigs (absence of irritation/sensitization) | Meets Biocompatibility Testing on White rabbits and Guinea Pigs | Biocompatibility testing (specifics of tests/sample size not detailed beyond animal models) |
  | Labeling | Meets FDA Specifications | Meets FDA Specifications | Labeling review against FDA guidelines |
  | Equivalence to Predicate Device (K000868) | Substantially equivalent to K000868 (except for color) | Substantially equivalent to K000868 (except for color) | Comparative review against predicate device specifications |

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

The document does not explicitly state the specific sample sizes used for each test (e.g., water leak, residual powder, tensile strength). It refers to compliance with the standards, implying that the sample sizes and methods prescribed within those standards were followed.

• Data Provenance: The manufacturing company is based in Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampacngpotch, Rattaphum, Songkhla 90180, Thailand). It is likely that the testing data was generated in Thailand or by laboratories compliant with international standards, but the exact country of origin for the data is not explicitly stated. The studies are retrospective in the sense that they were conducted on the manufactured product to demonstrate compliance with existing standards.

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

This information is not applicable in this context. The "ground truth" for medical gloves is established by meeting predefined physical and chemical performance standards (e.g., ASTM, ISO standards) rather than by expert clinical consensus or interpretation of diagnostic images. The standards themselves define the acceptable parameters for mechanical properties, barrier integrity, and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to resolving discrepancies in expert opinions, which is not relevant for testing physical properties of a device against objective standards. The outcome of the tests (e.g., does it leak or not, what is the tensile strength) is typically a quantifiable measurement or a pass/fail determination based on predefined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a physical medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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 medical glove, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these gloves is defined by:

• Performance Standards: The specifications outlined in ASTM D6319-00aE3, ISO 2859-1, ASTM D5151-06, and ASTM D6124-06. These standards define the acceptable physical properties (e.g., tensile strength, elongation), barrier integrity (water leak test), and chemical characteristics (residual powder).
• Biocompatibility Standards: Established protocols for testing biological reactions on animal models (White rabbits and Guinea pigs).

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not a machine learning model. There is no "training set." The manufacturing process is subject to quality control, and batches of gloves are sampled for testing against the standards.

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

This is not applicable for the same reason as point 8.

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This Non-Sterile, Powder-Free, Black Nitrile 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.

Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.

The acceptance criteria and device performance for the Non-Sterile, Powder-Free, Black Nitrile Examination Gloves are detailed below, based on the provided document K061553.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the exact sample size used for each individual test (e.g., number of gloves tested for watertightness, length, etc.). However, for the watertight test, it references "Multiple Normal GII" with an AQL (Acceptable Quality Level) of 2.5, which implies a statistically determined sample size based on lot size, as per ASTM standards for inspection.
• Data Provenance: The document does not specify the country of origin of the data. It is presented as summary performance data based on ASTM D6319-00a and FDA 1000ML watertight tests conducted by the manufacturer, YTY Industry (Manjung) Sdn Bhd, located in Malaysia. The nature of these tests (dimensional, physical property, chemical testing) suggests they are laboratory-based tests rather than human subject data, thus the terms "retrospective or prospective" are not directly applicable in the biological or clinical sense but rather describe the execution of a standardized test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a medical glove, and the "ground truth" for its performance is established through adherence to standardized physical and chemical specifications, not through expert clinical interpretation. The performance data is objective and measurable against the ASTM D6319-00a standard. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense is not applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The "tests" are objective measurements against a standard, not interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance is the objective measurements and specifications defined by the ASTM D6319-00a standard for nitrile examination gloves. These include physical properties (length, width, thickness, tensile strength, elongation) and chemical properties (powder content), as well as a watertightness test.

8. The sample size for the training set:

Not applicable. This device is a physical product, a medical glove, and does not involve AI or machine learning models that require a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

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