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The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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 Yellow Latex Examination Gloves With Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Non-Sterile, Powder-Free Yellow Latex Examination Gloves with Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove."

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Informs the company about their regulatory responsibilities, general controls, and where to find more information.
• States the intended use of the device.

It does not contain details about specific performance acceptance criteria for the gloves, nor does it describe any study (including sample sizes, ground truth establishment, expert qualifications, or MRMC studies) conducted to demonstrate compliance with such criteria.

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A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.

The provided documents describe the performance of "Non-sterile, Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs" (K101822) against various acceptance criteria relevant to medical examination gloves and specifically for their resistance to chemotherapy drugs.

Here’s a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on established ASTM (American Society for Testing and Materials) standards and a comparison to a legally marketed predicate device (K082957). The key performance indicator for chemotherapy drug resistance is the "Breakthrough Detection Time" as per ASTM D6978-05.

Acceptance Criteria and Reported Device Performance for K101822

Summary of Study Proving Acceptance:

The device K101822 was shown to meet its acceptance criteria through various tests described in the "Substantial Equivalence Discussion" (Document 2, page 2 of 2) and the "CONCLUSION" (Document 4, page 1 of 1). The primary study for chemotherapy drug resistance was conducted according to ASTM D6978-05. For other characteristics like dimensions, physical properties, freedom from pinholes, and powder-free status, the device was tested against and found to meet ASTM D6319-00a-05, ISO 2859-1 (for water leak test), ASTM D5151-06 (for detection of holes), and ASTM D6124-06 respectively. Biocompatibility tests included Primary Skin Irritation in Rabbits and Guinea Pig Maximization tests.

The device's performance was directly compared to a legally marketed predicate device, Siam Sempermed Corp. Ltd.'s Non-sterile, Powder-free Nitrile Examination Glove (K082957), showing substantial equivalence in all tested parameters, except for highlighting the short permeation times for Carmustine (BCNU) and Thiotepa, for which the gloves are explicitly not approved.

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

• Sample Size for Test Set: The specific sample sizes for each test (e.g., number of gloves tested for chemotherapy permeation, number of rabbits/guinea pigs for biocompatibility, or specific counts for physical properties) are not explicitly stated in the provided documents. The documents only state that the device "Meets ASTM D6319-00a-05," "Meets ASTM D6124-06", etc., which implies that the testing was performed according to the methodologies and sample size requirements specified in those respective ASTM/ISO standards.
• Data Provenance: The data is presented as part of a 510(k) Premarket Notification submission to the FDA by SGMP Company Limited, located in Thailand (Document 0, page 1 of 2). This indicates the testing was conducted by or on behalf of the manufacturer, and generally, such data would be generated in a controlled laboratory environment. The documents do not specify the country of origin of the specific lab that conducted these tests, but the manufacturer is based in Thailand. The studies were retrospective in the sense that they were conducted to characterize the finished medical device for regulatory submission, rather than as part of a clinical trial.

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

This question is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established through standardized laboratory tests (e.g., ASTM standards) measuring physical and chemical properties, not through expert human interpretation or clinical ground truth. Therefore, there are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy, nor are their qualifications relevant here.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., for image interpretation) to resolve disagreements among experts. The performance of these gloves is determined by objective, quantitative laboratory measurements according to published 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 question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers evaluate cases with and without AI assistance. This submission describes an examination glove, which is a physical barrier device, and does not involve human readers or AI assistance.

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

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

7. The type of ground truth used

The ground truth used for performance validation is based on objective, quantitative measurements obtained through standardized laboratory testing protocols, primarily from ASTM standards (D6319-00a-05, D6124-06, D6978-05) and ISO 2859-1. For biocompatibility, the ground truth is established by the observed biological responses in animal models (rabbits and guinea pigs) according to standardized tests for skin irritation and sensitization. The device's performance is then compared against the requirements specified in these standards and against the performance of a legally marketed predicate device.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI model or algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for this type of device.

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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 Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less) 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 latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and the study conducted for "Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less)."

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Water Tight Test: 125 pieces for each glove size (X-Small, Small, Medium, Large) for both un-aged and aged conditions. This totals 1000 gloves tested (125 * 4 sizes * 2 conditions).
• Sample Size for Physical Properties: Not explicitly stated but implied to be sufficient for testing tensile strength and ultimate elongation for each size, both before and after aging.
• Sample Size for Total Residual Powder Content: Not explicitly stated, but a range and mean are provided, suggesting multiple measurements.
• Sample Size for Residual Protein Level: Not explicitly stated, but the "Claimed Level" implies testing was performed.
• Data Provenance: The report is submitted by SGMP Company Limited, located in Thailand. The testing standards (ASTM) are international. The data is retrospective, as it's presented as the results of completed tests.

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

This type of information is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by objective, standardized laboratory tests according to ASTM (American Society for Testing and Materials) standards, such as D3578-05 for latex examination gloves, D6124-06 for residual powder, and D5712-99 for protein level. There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. Physical and chemical properties of gloves are measured using standardized test methods, not through 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 a submission for a medical device (examination gloves), not an artificial intelligence (AI) diagnostic or assistive technology. Therefore, no MRMC or AI-related effectiveness study was performed.

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

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the gloves' performance is based on objective, standardized test methods and specifications outlined in:

• ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application (for dimensions, physical properties, and water-tightness AQL).
• ASTM D 6124-06 for Total Residual Powder Content.
• ASTM D 5712-99 for Residual Protein Level.
• Biocompatibility tests (details in Appendix H, not provided, but implying standard in vitro/in vivo biocompatibility assessments).

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component requiring a "training set" for this medical device.

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

Not applicable, as no training set was used.

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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

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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The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (50 Micrograms or less) 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 latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

This document describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (50 Micrograms or Less)" submitted by SGMP Company Limited.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Dimension, Physical Properties, Residual Powder Content, Presence of Cornstarch, Residual Protein Level: The sample sizes for these tests are not explicitly stated for individual characteristics beyond the Water Tight Test. Data is reported for Lot #7023.
• Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested, both un-aged and aged. This totals 1000 gloves (125 gloves x 4 sizes x 2 aging conditions).
• Data Provenance: The document states "Internal SGMP'S" for the residual powder content, indicating the data was generated internally by the manufacturer. The country of origin of the manufacturer is Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand). The data appears to be prospective testing for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a physical product (latex examination gloves), and its performance is evaluated against established physical, mechanical, and chemical standards (e.g., ASTM standards, FDA requirements) rather than subjective expert interpretation of data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Performance is measured against objective standards, not subjective assessments requiring adjudication.

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

Not applicable. This is not a diagnostic device or a device involving human interpretation of outputs. Therefore, an MRMC study is irrelevant.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies of the device (the examination gloves) against defined standards and criteria, without human-in-the-loop performance being a factor for its primary function.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements. Specifically:

• ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application for dimensions, physical properties (tensile strength, ultimate elongation), and water tight test AQL.
• FDA specified 1,000 ml water leak test procedure.
• ASTM D 6124-06 for Residual Powder Content.
• ASTM D 5712-99 for Residual Protein Level.
• General biocompatibility tests for examination gloves (details in Appendix K, not provided).

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI algorithms that require a "training set." The product is a manufactured good tested against specifications.

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

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

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This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (50 Micrograms or less) 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 latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves

This report summarizes the acceptance criteria and device performance for the "POWDER-FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)" developed by SGMP Company Limited. The information is extracted from the provided 510(k) summary (K07/060).

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ASTM D3578-01aE2 and ASTM D3578-00aE2 standards for latex examination gloves, as well as FDA requirements for powder-free gloves and protein labeling.

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

• Dimension: Specific sample sizes are not explicitly stated, but the "SGMP" column provides data ranges or single values, implying testing was done.
• Physical Properties: For "Lot# 6171," the test results are reported for X-Small, Small, Medium, and Large sizes, both before and after aging. No specific number of gloves per size within Lot# 6171 is provided for these physical properties.
• Water Tight Test: 125 pieces of each glove size (X-Small, Small, Medium, Large) from "Batch # 6171" were tested, both un-aged and aged, for a total of 8 batches of 125 gloves (1000 individual gloves).
• Residual Powder Content & Presence of Cornstarch: The results are reported as a range and mean for residual powder, and a single "Negative" for cornstarch, indicating testing was performed, but specific sample size is not mentioned.
• Residual Protein Level: No specific sample size is given for this test.

Data Provenance: The data appears to be retrospective and gathered from internal testing conducted by SGMP Company Limited (Thailand), the manufacturer of the device. The data is presented as direct test results from their products, measured against established standards.

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

This information is not provided in the given text. For medical devices like examination gloves, the "ground truth" is typically defined by adherence to established industry standards (like ASTM) and regulatory requirements (like FDA's AQL for pinholes). These standards are developed through a consensus process involving experts in the field, but individual expert adjudication of specific test results for this 510(k) submission is not described. The manufacturer reports their own test results against these predefined standards.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies involving human interpretation or expert evaluation, often in medical imaging or diagnostic contexts, where there might be disagreement among initial assessors.

For this device (examination gloves), the "adjudication" is essentially the direct measurement and comparison of physical and chemical properties against objective, predefined industry and regulatory standards. There is no indication of human expert adjudication of individual test outcomes beyond the standard quality control and laboratory procedures to ensure accurate measurements. The reported values are direct measurements (e.g., tensile strength, length, number of leaks) that are then compared to the numerical thresholds set by the standards.

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. MRMC studies are typically performed for diagnostic devices where human readers interpret medical data (e.g., radiologists interpreting images) and the AI's effect on their performance is evaluated. This submission is for medical examination gloves, which do not involve human interpretation of data in the same way, nor the use of AI.

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

No, a standalone (algorithm-only) study was not done, as this product is not an AI/algorithm-driven device. The performance described is purely for the physical product itself, based on direct physical and chemical testing.

7. The Type of Ground Truth Used

The ground truth used for this study is primarily established industry standards and regulatory requirements. Specifically:

• ASTM D3578-01aE2 and ASTM D3578-00aE2 Standard Specifications for Latex Examination Gloves for Medical Application: These standards define the acceptable ranges and minimums for dimensions, tensile strength, ultimate elongation, and AQL for pinholes.
• FDA requirements: Such as the 1,000 ml water leak test for pinholes and the maximum limit for residual powder content (2 mg/glove).
• Other ASTM standards: ASTM D 6124-00 for residual powder content and ASTM D 5712-99 for residual protein level.

These standards serve as the objective benchmarks against which the device's performance is measured.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product (examination gloves), not an AI/machine learning model that requires a "training set." The information provided describes the testing of the manufactured product directly against established performance criteria.

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

This concept is not applicable. As there is no AI/machine learning model, there is no "training set" or ground truth for such a set to be established. The ground truth for evaluating the physical product is defined by the existing ASTM and FDA standards.

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The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) 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 latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Water Tight Test): 125 pieces for each size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 125 * 4 * 2 = 1000 gloves tested for water tightness.
• Sample Size (Physical Properties): Not explicitly stated how many gloves were tested for each physical property (Tensile Strength, Ultimate Elongation) for each size, but the results are reported for each size on "Lot# 4144."
• Data Provenance: The data is retrospective and comes from internal testing conducted by SGMP Company Limited, a company located in Thailand.

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

Not applicable to this type of device (patient examination gloves). The testing involves objective, measurable physical and chemical properties rather than expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., dimension, tensile strength, water leak count, chemical analysis).

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 a medical device (examination glove), not an AI diagnostic or interpretive tool. There are no "human readers" interpreting data.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-01aE2 (Standard Specification for Latex Examination Gloves for Medical Application) for dimensions and physical properties.
• ASTM D3578-00aE2 (a previous version of the same standard) for physical properties and water-tightness (2.5% AQL).
• FDA specified 1,000 ml water leak test for water tightness.
• ASTM D 6124-00 for Residual Powder Content.
• FDA requirements for powder content and protein labeling claims.
• Biocompatibility test standards (referenced in APPENDIX K).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the "NON-STERILE POWDER FREE BLUE NITRILE EXAMINATION GLOVES WITH VANILLA SCENTING," a patient examination glove. The provided text outlines the device's classification, intended use, and its equivalence to a predicate device, but it lacks detailed information regarding specific performance acceptance criteria and study data typical for AI/ML device evaluations.

Therefore, for aspects related to AI/ML device evaluation, the information is not available in the provided text. The following describes the available information focused on the
glove's conformity to standards.

Acceptance Criteria and Device Performance for Powder-Free Blue Nitrile Examination Gloves with Vanilla Scenting

The acceptance criteria for this device are based on its conformity to recognized industry standards for patient examination gloves. The performance of the device is reported as meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The provided summary does not detail a specific "test set" in the context of sampling a batch of gloves for evaluation. Instead, the device's performance is stated as meeting the requirements of a recognized standard, ASTM-D6319-00aE1. This standard outlines various tests (e.g., physical properties, barrier integrity) that examination gloves must pass. The glove manufacturer is responsible for ensuring ongoing compliance through their quality system, which would involve sampling and testing according to the standard's guidelines. The document does not specify the country of origin of the data or whether the data is retrospective or prospective, as it implicitly refers to adherence to a standard rather than a specific study.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. For examination gloves, "ground truth" is established by adherence to specified physical and chemical properties defined in standards like ASTM-D6319-00aE1, rather than through expert consensus on diagnostic images or clinical outcomes. The experts would be professionals in materials testing, quality control, and regulatory compliance who ensure the manufacturing process and product meet the standard's specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjectively assessed data, such as medical image interpretation, to resolve discrepancies among experts. For glove performance, objective measurements against technical specifications dictate acceptance.

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

This information is not applicable. An MRMC study is relevant for evaluating the effectiveness of a diagnostic tool, such as how AI assistance improves human interpretation of medical images. This device is a medical glove, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. This device is a physical medical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective measurements against established technical specifications and performance criteria outlined in the ASTM-D6319-00aE1 standard. This includes physical properties (e.g., tensile strength, elongation), dimensions, and barrier integrity (e.g., pinhole detection). It does not involve expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This product is a medical glove, manufactured according to established processes and tested against standards. There is no AI model or training involved in its development as described.

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

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

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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 patient and examiner.

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device: "Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (<50uG/G)".

The document describes the device's acceptance criteria and how its performance was demonstrated.

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Water Tight Test Results (LOT# 2206):

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

• Sample Size:
  • For Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged conditions, totaling 1000 gloves.
  • For Physical Properties (Tensile Strength, Ultimate Elongation): Lot# 2206 was tested, but specific sample sizes for each measurement are not explicitly stated beyond lot number. However, ASTM D3578-01aE2 typically defines sampling plans.
  • For Residual Powder Content: Not specified beyond a "Range" and "Mean."
  • For Biocompatibility: "the gloves passed the tests in question records" in Appendix M suggests testing was performed according to guidelines, but sample size is not stated.
• Data Provenance: The document does not specify the country of origin of the data. It implies retrospective testing on manufactured gloves (Lot# 2206).

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

This information is not applicable to this type of device (patient examination gloves). The "ground truth" for the performance of these gloves is established through standardized physical, chemical, and biological tests based on established specifications like ASTM-D3578-01aE2 and FDA requirements, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable. As stated above, performance is measured against objective standards, not through adjudication of expert interpretations.

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 physical, non-AI medical device (patient examination gloves), and therefore, no MRMC study involving human readers or AI assistance was performed.

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 device, not an algorithm, so no standalone algorithm performance study was done.

7. The Type of Ground Truth Used:

The ground truth used is based on:

• Standard Specifications: ASTM-D3578-01aE2 "Standard Specification for Latex Examination Gloves for Medical Application."
• FDA Internal Requirements: For water tight tests, residual powder content, and specified protein labeling claim (<50 µg/g).
• Biocompatibility Standards: Implied by "passed the tests in question" as per Appendix M.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical device, not an AI/ML algorithm 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 type of device.

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