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Disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Nitrile Examination Gloves Powder Free (Blue) product (K210868).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Holes in Medical Gloves (ASTM D5151-19): An acceptance criterion of "5 out of 125 pieces sample size" is specified, implying a sample size of 125 pieces was used for this test.
• Sample Size for Residual Powder (ASTM D6124-06): While the acceptance criterion is ≤ 2 mg/glove, the specific sample size used for this test is not explicitly stated, only that the result was 0.70 mg/glove.
• Sample Size for other tests (Length, Width, Thickness, Physical Properties): The specific sample sizes for these tests are not explicitly mentioned in the provided text.
• Data Provenance: The studies were non-clinical performance tests conducted by Great Eco Glove Sdn. Bhd., a company located in Malaysia. The type of data is laboratory test results. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed on batches of the actual device.

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

Not applicable. The ground truth for this device (nitrile examination gloves) relies on standardized objective measurements and chemical/physical properties as defined by ASTM and ISO standards, not expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and adherence to specified ranges or limits outlined in the standards, rather than subjective interpretation 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-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.

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

Not applicable. As stated above, this device is a medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and objective measurements. Specifically, the adherence to physical characteristics (length, width, thickness, tensile strength, ultimate elongation), absence of holes, and residual powder content are verified against the requirements set by:

• ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility)

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product whose performance is evaluated through non-clinical laboratory testing.

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

Not applicable. There is no training set for this type of device. The "ground truth" for the device's performance is defined by the technical specifications and limits set forth in the aforementioned ASTM and ISO regulatory standards.

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The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) summary for a disposable powder-free nitrile examination glove, and as such, it focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe an AI medical device, and therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text for the physical characteristics of the glove.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document refers to "bench testing" and compliance with ASTM standards and ISO standards. These standards typically involve specific sample sizes and testing methodologies defined within the standard itself. The document does not explicitly state the exact number of units tested for each specific criterion. Data provenance is not specified beyond "bench testing" implies laboratory testing of the physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device (nitrile examination glove) and not an AI/ML medical device where expert ground truth for interpretation would be required. The "ground truth" here is the pass/fail result against established material and performance standards.

4. Adjudication method for the test set
Not applicable, as this is bench testing of physical properties against established standards, not an AI output requiring expert 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 is not an AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI medical device.

7. The type of ground truth used
The "ground truth" for the device's performance is based on established national and international standards for medical gloves, specifically:

• ASTM D6319-10 (Reapproved 2015) - Standard specification for Nitrile Examination Gloves
• 21 CFR 800.20 - Freedom from holes
• ASTM D5151-06 (Reapproved 2015) - Test method for detection of holes in medical gloves
• ASTM D6124-06 (Reaffirmation 2011) - Test method for residual powder on medical gloves
• ISO 10993-10: Third Edition 2010-08-01 - Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
• ISO 10993-5: Third Edition 2009-06 - Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

8. The sample size for the training set
Not applicable. This is not an AI medical device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI medical device.

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