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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., separate sample sizes for physical properties, pinholes, etc.). However, it refers to compliance with ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is from Ug Global Resources Sdn Bhd, based in Malaysia, indicating the tests were conducted by the manufacturer for their 510(k) submission. The type of study is retrospective, as it describes tests performed on existing glove samples to demonstrate compliance with standards.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized, objective tests outlined in ASTM and ISO standards, not by expert consensus or interpretation of subjective data.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in medical imaging or clinical trial settings where there's subjective interpretation by experts. For glove testing, the results are quantitative measurements against predefined thresholds in the standards.

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 information is not applicable. This is a submission for a medical device (examination gloves), not an AI algorithm or diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for this device is based on objective measurements and performance criteria defined by international and national standards, specifically:

• ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves
• ISO 10993-10:2002: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

These standards provide the methodology and acceptable limits for various properties like dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.

8. The sample size for the training set:

This information is not applicable. This is not an AI/machine learning study that involves training and test sets. The glove's performance is evaluated against established standards through direct testing.

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

This information is not applicable for the reasons stated in point 8.

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The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim

Here's a breakdown of the acceptance criteria and the study information for the "Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free PEACH Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent

This document is a 510(k) premarket notification approval letter for examination gloves. It does not contain information regarding software or AI/ML acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information.

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These Non-Sterile, Powder-Free, AQUA NITRILE Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, Powder Free, AOUA NITRILE Examination Gloves with Lano- E and Peppermint Citrus Scent

I cannot fulfill this request. The provided text is a Food and Drug Administration (FDA) clearance letter for a medical device (examination gloves), not a study report or clinical trial documentation. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt. This document attests to the substantial equivalence of the device to legally marketed predicate devices, but it does not present the results of a study that would "prove the device meets acceptance criteria" in the way described in the prompt.

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The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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.

Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.

The provided document is a 510(k) premarket notification for "Non-Sterile, Powder-Free, Latex Examination Gloves" and does not describe a study involving an algorithm or AI. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets them in the context of AI/algorithm performance.

However, I can extract the acceptance criteria and reported performance for the latex examination gloves as presented in the document, which primarily focuses on physical and chemical properties of the gloves.

Here's the information based on the provided text, adapted to the closest relevant categories:

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

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

Lano-E Powder-Free Nitrile Examination Glove. Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A. Powder Residue: Maximum 2mg/glove. Material: Nitrile. Cuff: Beaded. Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.

This looks like a 510(k) submission for examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human reader improvement with AI) is not applicable to this document.

The document describes the device, its intended use, and its compliance with ASTM standards for physical properties. The "study" here is essentially the testing performed to ensure the gloves meet these established standards.

Here's the relevant information adapted to the context of this device:

Acceptance Criteria and Device Performance (for Lano-E Powder-Free Nitrile Examination Glove)

The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.

1. Table of Acceptance Criteria and Reported Device Performance

Inspection Parameters (Acceptance by Inspection Level and AQL)

Physical Properties (Before Aging)

Physical Properties (After Aging)

Note: The document explicitly states: "The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging." This implies that the device performance met all listed acceptance criteria.

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

• Sample Size: The document does not specify a precise sample size for the testing of each individual criterion. However, the testing was conducted "in compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999". These standards typically define the sampling plans (e.g., AQL tables) for quality control and testing.
• Data Provenance: The device manufacturer, N.S. Uni-Gloves Sdn. Bhd., is based in Malaysia. The testing data would have been generated internally by the manufacturer or by a contracted laboratory following the specified international standards. The data is retrospective in the sense that it was collected as part of the product development and quality assurance process prior to the 510(k) submission.

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

• Not Applicable: For this type of device (examination gloves), "ground truth" is established by adherence to measurable physical and chemical specifications outlined in established industry standards (like ASTM and EN standards). There are no "experts" in the sense of clinical reviewers establishing a subjective truth. The "truth" is objective measurement against a standard.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For examination gloves, the testing involves objective measurements (e.g., dimension, tensile strength, water tightness), which do not require human adjudication in the traditional sense. The pass/fail is determined by whether the measured value falls within the specified range or meets the AQL.

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 an examination glove, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

• Not Applicable: This is an examination glove. There is no algorithm or AI component involved.

7. The type of ground truth used

• Objective Standards and Measurements: The "ground truth" is defined by the objective, quantifiable specifications outlined in recognized international standards (ASTM D 6319-00 Rev A, EN 455 series, ISO 2859-1:1999) and the FDA 1000ml water tight test. This includes material properties, physical dimensions, and defect rates.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of examination gloves. The manufacturing process is controlled to produce gloves that consistently meet the specifications. Continuous quality monitoring, potentially using statistical process control, ensures ongoing adherence.

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

• Not Applicable: As there is no training set, this question is not applicable. The design and manufacturing process for the gloves are based on achieving the objective criteria defined by the standards.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00
Material: Latex
Cuff: Beaded
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

The provided document describes the acceptance criteria and the study results for the UniGlove Lano-E Powder-Free Latex Examination Gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

"Meets" or "In compliance" implies the device performed within the specified acceptance criteria. Specific numerical results for each criterion are not provided in the summary, only the conclusion that they meet the standards.

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

The document does not explicitly state the specific sample sizes used for testing each criterion. However, it indicates that the quality assurance is in compliance with ASTM D3578-00, which would dictate the sampling plans and statistical methods for determining compliance.

• Data Provenance: Not explicitly stated, but the submission is from N.S. Uni-Gloves Sdn. Bhd. (Malaysia), suggesting the testing likely occurred there or was conducted on products manufactured there. It is a premarket notification for a medical device; thus, the data would be prospective for the purposes of demonstrating regulatory compliance.

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

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective physical and chemical testing against defined standards (ASTM D 3578-00 and FDA 1000 ml water test). It does not involve expert interpretation or subjective assessment of images or medical conditions.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical imaging) where discordant expert opinions need resolution. For physical and chemical properties of gloves, objective measurements are taken, eliminating the need for adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This device is a patient examination glove, which does not involve human interpretation in its primary function for performance evaluation in this context.

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

This concept is not applicable to the UniGlove Lano-E Powder-Free Latex Examination Gloves. "Standalone" performance refers to an algorithm's ability to perform a task without human intervention, typically in AI/ML applications. A glove's performance is determined by its physical and chemical properties, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises objective measurements against established national and international standards. Specifically:

• ASTM Standard D 3578 - 00: For physical properties (dimensions, tensile strength, elongation, pinhole AQL).
• FDA 1000 ml water test: For water tightness/pinhole integrity.
• EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989: Other international standards for quality assurance.
• Specific material properties: Powder residue limit, protein content claim.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (examination glove) whose performance is evaluated against material and manufacturing standards. There is no "training set" in the context of machine learning or AI models for this device.

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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