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The Examination gloves-Type A (Latex 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.

The proposed device, The Examination gloves-Type A ( Latex 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. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.

This document is a 510(k) summary for Examination gloves-Type A (Latex gloves). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical performance test data to demonstrate substantial equivalence.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Watertight test: 200 pieces (gloves).
• Sample Size for other tests: The document specifies "Minimal for all sizes" or "for all sizes" without providing explicit sample counts for each specific physical and chemical test.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. All submissions are from China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a physical medical device (examination gloves), not an AI/software device that requires expert adjudication for ground truth related to image interpretation or diagnosis. The "ground truth" for these tests is established by standardized methods and measurements as defined by ASTM and ISO standards, not by expert consensus. Therefore, this question is not applicable in the context of these non-clinical performance tests.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/imaging studies where there might be inter-reader variability. For the physical and chemical tests conducted on examination gloves, the determination of pass/fail is based on objective measurements against predefined acceptance criteria from international standards. There is no mention of an adjudication method as it is not relevant to this type of testing.

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

This question is not applicable. The device in question is examination gloves, not an AI-assisted diagnostic tool. Therefore, MRMC studies or assessments of human reader improvement with AI assistance are irrelevant.

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

This question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.

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

The "ground truth" for the performance tests on these examination gloves is based on:

• Standardized measurement and testing protocols: Adherence to established international standards (ASTM and ISO).
• Objective physical and chemical properties: Measurements of dimensions, tensile strength, elongation, residual powder, protein content, and biological reactivity (skin sensitization, irritation, systemic toxicity).
• Defined Pass/Fail criteria: Each test has specific numerical or qualitative acceptance criteria derived from the respective standard.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

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

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The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Disposable Sterilized Latex Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5. The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.

This document is a 510(k) summary for Disposable Sterilized Latex Surgical Gloves, demonstrating substantial equivalence to a predicate device (K171550). It focuses on non-clinical performance data and does not involve AI or clinical studies as typically defined in medical imaging or diagnostic device contexts. Therefore, many of the requested points are not applicable.

Here's an analysis of the provided information in the context of the requested questions:

Acceptance Criteria and Device Performance

This product is a medical device (Disposable Sterilized Latex Surgical Gloves), not an AI algorithm. The "acceptance criteria" and "reported device performance" are based on physical, chemical, and biological properties of the gloves, compared against recognized ASTM and ISO standards.

Table of Acceptance Criteria and Reported Device Performance:

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The Examination gloves-Type C (Nitrile 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.

The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only.

This document summarizes the acceptance criteria and performance data for Examination gloves - Type C (Nitrile gloves), as presented in the provided FDA 510(k) Premarket Notification.

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 specific sample sizes for each test within the "Non-Clinical Testing" section. However, the tests are conducted in conformance with recognized international and national standards (ASTM, ISO), which typically specify appropriate sample sizes and methodologies.

The provenance of the data is not explicitly stated in terms of country of origin, but it is derived from non-clinical laboratory testing performed by the manufacturer, Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., located in Nanchang City, Jiangxi Province, China. The data is retrospective, as it represents results from tests already performed on the finished device to demonstrate compliance.

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

This information is not applicable. The device in question is a physical medical device (examination gloves), and the "ground truth" for its performance is established through objective, standardized laboratory tests (e.g., water leakage for pinholes, mechanical strength tests, chemical analysis for residual powder, and biological safety assessments). These are not typically assessed by human experts establishing a "ground truth" in the way, for example, a radiologist would for an AI image analysis system.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed are objective, quantitative measurements or qualitative observations (e.g., "no irritation") based on standardized protocols rather than subjective interpretations requiring adjudication among multiple human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This document pertains to non-AI-powered examination gloves.

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

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or software requiring a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the performance of the examination gloves is established through:

• Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., D5151-19 for holes, D6319-19 for physical properties, D6124-06 for residual powder) and ISO (e.g., 10993-10 for irritation/sensitization, 10993-11 for systemic toxicity).
• Objective Measurements: Quantitative measurements (e.g., length, width, thickness, tensile strength, elongation, residual powder amount) with defined acceptable ranges.
• Biological Assessments: Standardized biological evaluations to determine irritation, sensitization, and systemic toxicity, with "no irritation," "no sensitization," and "no acute systemic toxicity" as the ground truth for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This device is an examination glove, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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