Search Results

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes

WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes

CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS

Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

This document describes two types of non-sterile, powder-free nitrile examination gloves:

1. Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
2. Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

The acceptance criteria for both devices are primarily based on their resistance to permeation by chemotherapy drugs, as tested according to ASTM D6978 Standard Practice. For the second device, resistance to Fentanyl Citrate is also included.

The study proving the device meets the acceptance criteria is detailed in the "Indications for Use" sections for each glove type.

1. Table of Acceptance Criteria and Reported Device Performance

Device 1: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue

Note: The document explicitly warns: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (11.3 minutes and 7.4 minutes, respectively). This implicitly sets an acceptance criterion that usage with these drugs is not recommended, rather than a performance threshold for them. For other drugs, a permeation time of "> 240 minutes" appears to be the target performance for safe use.

Device 2: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue

Note: The document states: "CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS". Similar to Device 1, this indicates that while tested, their permeation times (30.3 minutes and 91.0 minutes, respectively) are lower than the target for other drugs, suggesting a cautionary use or implicit lower acceptance for these specific substances.

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

The document specifies that the gloves were "tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

• Sample Size for the Test Set: The document does not explicitly state the sample size (e.g., number of gloves or tests performed per drug) used for these tests. The ASTM D6978 standard would likely specify the required number of replicates.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted by YTY Industry (Manjung) Sdn Bhd, located in Malaysia, suggesting the tests were performed in Malaysia. The nature of laboratory testing like this is inherently prospective for the specific batch or design of gloves being evaluated.

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 in the context of this document. The "ground truth" here is the physical measurement of chemical permeation, determined by laboratory testing methods described in ASTM D6978, rather than expert interpretation of medical images or diagnostic data. There is no indication of experts being used to establish a ground truth for the test results.

4. Adjudication method for the test set

This question is not applicable. The test results are objective chemical permeation measurements (breakthrough detection time), not subjective interpretations that require adjudication by experts.

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 is a medical glove, not an AI-powered diagnostic tool requiring human interpretation or MRMC studies.

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 medical glove, not an algorithm. The performance described is that of the physical product itself.

7. The type of ground truth used

The ground truth used is laboratory measurement of chemical permeation according to the ASTM D6978 standard. This standard describes methods to evaluate the resistance of medical gloves to permeation by chemotherapy drugs, typically by detecting the breakthrough of a specific chemical through the glove material over time.

8. The sample size for the training set

This question is not applicable. The device consists of physical gloves, not a machine learning model, and therefore does not have a "training set" in the computational sense. The manufacturing process of gloves might involve quality control and material testing, but this is distinct from training a dataset for an algorithm.

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

This question is not applicable, as there is no "training set" for this physical device.

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle 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 for over-the counter single use.

The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.

Warning Statements related to acceptance/use:

• Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."
• Cobalt Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."

Study Proving Device Meets Acceptance Criteria:

The device's performance is demonstrated through testing against recognized standards. The document is a 510(k) summary for premarket notification, which means the manufacturer conducted tests to show substantial equivalence to a legally marketed predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, water tightness, or biocompatibility). The testing is generally indicated as "Meets" specific ASTM/ISO standards, which typically prescribe minimum sample sizes for conformity testing.
• Data Provenance: The tests were conducted to support a premarket notification for devices manufactured by YTY Industry (Manjung) Sdn Bhd in Malaysia. This suggests the data originates from tests conducted by or for the manufacturer, likely in an accredited lab to demonstrate compliance with the referenced international standards. The data is retrospective in the context of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate device characteristics.

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 testing (e.g., permeation time, physical properties) is established through standardized laboratory methods and instrument readings, not expert consensus or interpretation of images.

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

This is not applicable as the determination of device characteristics (e.g., breakthrough time, physical dimensions) is based on objective measurements and standardized test protocols, not on human 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:

This is not applicable. This document describes performance testing for medical gloves, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable as the 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 performance claims of these gloves is based on:

• Standardized Test Methods: Adherence to established international standards like ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, and ISO 10993-10.
• Objective Measurements: Laboratory measurements of physical properties (e.g., dimensions, thickness, water leakage, powder content) and chemical permeation breakthrough times using specified equipment and protocols.

8. The sample size for the training set:

This is not applicable. The device is a manufactured good (gloves), not an AI model requiring a training set.

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

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

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle 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 for over-the counter single use.

This document is a 510(k) Pre-market Notification for medical gloves, focusing on their resistance to chemotherapy drugs. It details the performance of "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue)" against a range of chemotherapy agents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for chemotherapy drug permeation are defined by the "Average Breakthrough Detection Time" for each drug. While the specific numerical acceptance criteria (e.g., minimum time) are not explicitly stated as distinct "criteria" separate from the results, the implication is that the longer the breakthrough time, the better the performance. For many drugs, a breakthrough time of "> 240 minutes" is presented, suggesting this is a desirable outcome or a de facto acceptance benchmark for long-term protection. The device performance is the directly measured average breakthrough detection time for each drug.

Below are the tables summarizing the performance for both "Original Blue" and "Cobalt Blue" glove variations, as tested against various chemotherapy drugs.

Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Original Blue

Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Cobalt Blue

In addition to chemotherapy drug permeation, the gloves were also tested against other specifications, including:

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 individual chemotherapy drug permeation or other properties. However, it does state that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250." These ASTM standards would typically define the appropriate sample sizes and testing methodologies.

The data provenance is not specified, but the submission is from "YTY Industry (Manjung) Sdn. Bhd., Malaysia," suggesting the tests were likely conducted on products manufactured or supervised by this Malaysian entity. The tests appear to be a prospective evaluation of the device's performance against established standards.

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

This document describes performance testing of physical properties and chemical permeation resistance of gloves, not diagnostic or clinical interpretation. Therefore, the concept of "experts used to establish ground truth" as it would apply to image analysis or clinical diagnosis is not applicable here. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-10 and D6978-05) and FDA regulations. These standards define the scientific methods and procedures for evaluating glove performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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 relevant for evaluating the impact of a device (often AI-based) on human reader performance in tasks like diagnostic interpretation. This document pertains to the physical and chemical performance of medical gloves, not assistive diagnostic technology.

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

Yes, a standalone performance assessment was done. The entire study described is a standalone evaluation of the glove's performance against various physical and chemical challenges, without human-in-the-loop interaction in the context of diagnostic interpretation. The breakthrough detection times and physical properties are direct measurements of the device's inherent characteristics.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and scientific testing procedures. Specifically:

• ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: This standard outlines the methodology for determining the breakthrough detection time of chemotherapy drugs through glove material.
• ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application: This standard sets specifications for physical properties like dimensions, physical performance, and powder content.
• ISO 10993-10 (2010) and Consumer Product Safety Commission II, Part 1500: These standards govern biocompatibility testing (primary skin irritation and dermal sensitization).
• ASTM D5151-06: This standard relates to water tightness testing.

The results obtained through these standardized testing methods serve as the "ground truth" for the device's performance.

8. The Sample Size for the Training Set

Not applicable. This device is a medical glove, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle 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 for over-the counter single use.

The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.

Here's the summary of the acceptance criteria and reported device performance:

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

Study Proving Device Meets Acceptance Criteria:

The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).

• Standards Used: The performance of the devices was evaluated against the following standards:

  • ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
  • FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
  • ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
  • ASTM-D6124-10 (Reapproved 2011) for Residual Powder.

• Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.

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 information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.

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 as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).

8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.

9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML device.

Ask a specific question about this device

A powder-free 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.

Non sterile, Powder free Nitrile Examination Glove, Blue.

The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.

The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.

Here's an analysis of the provided information, addressing the applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.

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

• Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
• Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated for the purpose of the 510(k) submission.

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

• Not Applicable. For this type of device (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.

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

• Not Applicable. This device is a physical product and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

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

Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for medical Application.

This document describes the acceptance criteria and performance data for non-sterile, powder-free nitrile examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The performance data of the gloves shown above meet the ASTM D6319-00a Standard and FDA's requirements.

Study Information:

This document is a 510(k) summary for a medical device and provides performance data based on established standards rather than a typical clinical study with patient data. Therefore, some of the requested information (like sample size for test/training sets from patient data, ground truth establishment by experts for medical AI, MRMC studies) is not applicable in this context.

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

The document refers to performance data based on ASTM D6319-00a and FDA 1000ML watertight test.

• Sample Size: Not explicitly stated as a single "test set" in terms of patient cases. The ASTM standard specifies how many gloves from a lot must be sampled and tested for each criterion (e.g., AQL for watertightness). The number of individual gloves tested for each property (length, width, thickness, physical properties, powder content) would be determined by the specific sampling plans outlined in ASTM D6319-00a.
• Data Provenance: The manufacturing company is stated as ULTRAWIN SDN BHD in Malaysia. The testing was conducted to meet international standards (ASTM) and FDA requirements. Therefore, the data originates from testing conducted by or for the manufacturer, likely in Malaysia or accredited testing facilities. The data is retrospective in the sense that it's a report of tests already performed on manufactured products.

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

Not applicable in the context of glove performance testing against technical standards. The "ground truth" for these tests is defined by the objective measurement methods and specifications within ASTM D6319-00a and FDA regulations. These are quantitative measurements that do not require expert consensus for interpretation in the way clinical diagnostic image interpretation would.

4. Adjudication Method for the Test Set:

Not applicable. The tests are based on objective measurements against specified ranges or thresholds (e.g., minimum length, maximum powder content, AQL for pinholes). There is no "adjudication" in the sense of resolving disagreements between human evaluators.

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 relevant for diagnostic or screening devices involving human interpretation (e.g., radiologists reading images) and comparison of performance with and without AI assistance. This document pertains to the physical and barrier properties of examination gloves.

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

Not applicable. This is a physical product, not a software algorithm. The "performance" is the inherent property of the glove itself, measured directly.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is based on objective measurement against established technical standards and regulatory requirements.

• ASTM D6319-00a Standard: This standard provides the specific test methods, acceptable ranges, and sampling plans for nitrile examination gloves.
• FDA Pinhole Requirements: Specifically, the 1000ml watertight test with an AQL of 2.5 is a regulatory requirement for barrier integrity.
• FDA Requirements for Powder Content: Stipulating a maximum of 2.0 mg/glove.
• Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization Test.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device