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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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.

The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.

Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

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

The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.

• Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.

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

Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.

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

Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes "training."

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

Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.

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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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19. The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile. The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.

The provided text describes the acceptance criteria and performance of "Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl". This is a medical device, specifically examination gloves, and therefore the "study" concerns non-clinical performance testing rather than studies involving human participants or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For Watertightness (ASTM D5151):
  • Small: 200 pcs
  • Medium: 315 pcs
  • Large: 315 pcs
  • Extra Large: 315 pcs
  • Double Extra Large: 200 pcs
• For other tests (Physical Properties, Dimension, Residual Powder, Biocompatibility, Chemotherapy Drug and Fentanyl Citrate Permeation): The specific sample sizes are not explicitly stated in the provided text. However, for these types of non-clinical tests, samples are typically drawn from manufacturing lots according to the requirements of the respective ASTM or ISO standards.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is a report of completed non-clinical performance and safety testing.

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. The document describes the performance of a physical medical device (gloves) through standardized non-clinical laboratory testing (e.g., tensile strength, chemical permeation) to establish its physical and chemical properties and safety. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices or AI algorithms, to resolve discrepancies in human expert interpretations or to establish a consensus ground truth. This document pertains to non-clinical laboratory testing of a tangible product.

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. The device is a physical examination glove, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and there is no AI assistance involved.

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 examination glove, not an algorithm, so there is no standalone algorithm performance to evaluate.

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

The "ground truth" for this device's performance is established by the accepted methodologies and metrics defined in the referenced ASTM and ISO standards for physical, chemical, and biocompatibility testing. For example:

• Physical properties (tensile strength, elongation) are measured objectively using a Tensile Testing Machine.
• Dimension (length, width, thickness) is measured using appropriate measurement tools.
• Watertightness is determined objectively by inspecting for holes after filling with water.
• Chemical permeation is physically measured based on the detection time of breakthrough.
• Biocompatibility is assessed through standardized in-vitro or in-vivo (animal) tests specified by ISO 10993 standards.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense of a diagnostic or therapeutic device for this type of product.

8. The sample size for the training set:

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

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

This is not applicable as there is no training set for a physical product.

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First Glove Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.

This document describes the acceptance criteria and performance of the "First Glove Blue Nitrile Examination Gloves Powder Free" based on non-clinical testing.

Here's the information requested:

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 individual test (e.g., number of gloves tested for dimensions, tensile strength, etc.). However, it indicates the tests were conducted according to the specified ASTM and ISO standards, which typically include defined sampling plans.

The data provenance is from non-clinical bench testing. The country of origin of the data is not explicitly stated in the provided text, but the applicant's address is Malaysia (First Glove Sdn. Bhd.).

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 as the evaluation is based on non-clinical, objective laboratory tests against established international standards (ASTM and ISO). There were no human expert assessments of images or patient data to establish ground truth in this context.

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

None. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. This submission relies on objective physical, chemical, and biological tests.

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 medical gloves, which are physical devices. MRMC comparative effectiveness studies are used for AI-powered diagnostic or interpretive tools, not for devices like gloves.

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

Not applicable. This is not an algorithm or AI-powered device.

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

The "ground truth" for the non-clinical tests is based on the objective and quantifiable criteria defined by the relevant ASTM and ISO international standards. For example, for tensile strength, the ground truth is a specific numerical value (e.g., ≥ 14 MPa). For biocompatibility, it's defined by biological endpoints (e.g., "non-irritant," "non-sensitizer," "non-cytotoxic").

8. The sample size for the training set:

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

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

Not applicable. As mentioned above, there is no training set for this type of device.

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Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.

The provided document details the acceptance criteria for "Blue Nitrile Examination Gloves Powder Free" and presents the results of non-clinical testing to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

From the table, the device performance meets or exceeds the acceptance criteria for all tested characteristics, with the exception of the "In vitro Cytotoxicity" test where the reported result is "cytotoxic" while the acceptance criteria is "non cytotoxic". This discrepancy needs clarification. However, in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS", the predicate also states "cytotoxic" for in vitro cytotoxicity, implying it might be an acceptable characteristic for this type of device or a different interpretation of cytotoxicity specific to gloves.

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

The document does not explicitly state the specific sample sizes used for each test. For example, for "Water Tight (1000 ml)" test, it mentions "Passes AQL-1.5", which implies a sampling plan was used according to the ASTM standard, but the specific number of gloves tested is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, beyond the fact that the tests were conducted according to international standards (ASTM, ISO).

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. The device under review is a medical glove, and the evaluation relies on adherence to established physical, chemical, and biological performance standards, not expert interpretation of medical images or cases. Ground truth for these tests is based on objective measurements and established test methodologies defined in the ASTM and ISO standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) where expert consensus is required. The testing for this device involves objective, quantitative measurements against predefined 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. The device is a medical glove. MRMC studies are relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with or without AI assistance.

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

This information is not applicable. The device is a medical glove, not an algorithm or AI system.

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

The ground truth for this device's performance is based on the objective measurements and predefined thresholds within recognized international standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017, USP 41). For example:

• Dimensions: Measured length and width against minimum/range requirements.
• Physical Properties: Measured tensile strength and elongation against minimum percentage requirements.
• Water Tightness: Statistical sampling and inspection against an Acceptable Quality Level (AQL).
• Biocompatibility: Observation of biological responses (e.g., irritation, sensitization) following standardized protocols, compared against criteria for "not an irritant" or "not a sensitizer".

8. The sample size for the training set

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

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

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

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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.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.

This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)

Physical Properties, Dimensional, and Biocompatibility Testing

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

The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.

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

Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.

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 devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.

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

Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
• Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.

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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Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is available in Small, Medium, Large and Extra Large sizes. The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

The provided document is a 510(k) premarket notification for "Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate." This document outlines the acceptance criteria and the results of a study to demonstrate the device's performance.

Here's the breakdown of the information requested based on the provided text:

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

The document provides extensive tables for the performance of the gloves. Rather than recreating the entire tables found on pages 10-14, a summary of key acceptance criteria and reported performance is presented below. Please refer to pages 10-14 of the original document for the complete lists of chemotherapy drugs and specific results.

Note on Cytotoxicity: The device itself is reported as cytotoxic under the tested conditions. This is a critical finding that does not meet a "Non cytotoxic" acceptance criterion. However, the FDA has still cleared the device. This implies that either the level of cytotoxicity observed is deemed acceptable for the intended use and risk-benefit profile of examination gloves, or mitigating factors/information were provided elsewhere (not in this summary). It's important to note this discrepancy.

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

The document lists various ASTM and ISO standards for testing, which define the sample sizes required for each test (e.g., AQL levels for watertightness). However, the specific quantity/sample size used for each individual test conducted by the manufacturer is not explicitly stated in this summary document beyond what's implied by the standard (e.g., AQL 1.5 for watertightness performance is a characteristic, not a sample size).

• Data Provenance: The manufacturing location of the device owner, JR Engineering & Medical Technologies (M) Sdn. Bhd., is in Malaysia (Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan, Malaysia). The testing was conducted in accordance with international standards (ASTM, ISO), implying that the data originates from laboratory studies, likely conducted by third-party labs or the manufacturer's own qualified labs, but the specific country of the testing labs is not mentioned.
• Retrospective or Prospective: The testing described is prospective laboratory performance testing of the device, rather than a retrospective analysis of existing data.

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 product is a medical glove, not an AI or imaging device requiring expert consensus for ground truth. The "ground truth" for this device's performance is established through objective, standardized laboratory testing (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 for biocompatibility). These tests rely on chemical and physical measurements, not human expert interpretation of images or clinical outcomes. Therefore, the concept of "number of experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable to this type of device. The "experts" are the technicians and scientists performing the standardized validation tests.

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

Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary (like in imaging diagnosis), there is no adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical examination glove, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device. The tests performed are "standalone" in the sense that they assess the intrinsic material properties and barrier performance of the glove itself.

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

The ground truth for this device is based on standardized, objective physical, chemical, and biological measurements obtained through laboratory testing, as defined by relevant ASTM and ISO standards. This includes:

• Physical measurements (e.g., length, width, thickness, tensile strength, elongation).
• Chemical analysis (e.g., residual powder, breakthrough detection time for drugs).
• Biological testing (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity).

8. The sample size for the training set

Not applicable. This device is a manufactured product (glove), not an AI algorithm or model 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 device.

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Ask a specific question about this device

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only. Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)":

1. A 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. For many of the physical and chemical property tests (e.g., dimensions, tensile strength, freedom from holes, residual powder, chemotherapy drug permeation), the relevant ASTM standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05) would specify the required statistical sampling plans, but the summary document only provides the results.

Similarly, for biocompatibility tests (ISO 10993 series), the number of animals or cell cultures used is not detailed in this summary, but the standards themselves outline the required protocols.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that these are bench and lab tests for a premarket notification, it's highly probable that the tests were conducted prospectively by the manufacturer or a contracted testing laboratory to demonstrate compliance with the referenced 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 and not provided since the studies performed are bench testing and biocompatibility testing against established international standards (ASTM and ISO). These types of tests do not typically involve human experts establishing a "ground truth" through interpretation, as would be the case for an AI diagnostic device. Instead, the "ground truth" is defined by the objective measurement parameters and criteria specified in the standard test methods themselves.

4. Adjudication method for the test set

Not applicable. As noted above, these are objective bench and lab tests against predefined specifications in standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. The results are quantitative measurements or direct observations (e.g., passes/fails 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 device is a medical glove, not an AI diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or would be relevant.

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

Not applicable. This device is a medical glove, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these nitrile examination gloves are the acceptance criteria defined by the relevant ASTM and ISO standards. These standards provide:

• Specific measurable thresholds (e.g., minimum length, minimum tensile strength, maximum residual powder).
• Defined test methods and methodologies (e.g., how to measure breakthrough time for chemotherapy drugs, how to assess irritation or sensitization).
• Statistical sampling plans (e.g., AQL for freedom from holes).

Compliance with these pre-defined, objective criteria from the standards constitutes the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical device (medical glove), not an AI model. 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 for a physical medical device.

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Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves Powder Free-Black are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free and non-sterile.

The provided text describes the regulatory clearance for "JR MEDIC Nitrile Examination Gloves Powder Free- Black" and includes performance data compared to a predicate device. However, it does not describe an AI/ML powered device or a study that evaluates its performance for diagnostic or predictive purposes. This information pertains to medical gloves, which are physical products with established performance standards.

Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

I will provide the available information from the text regarding the acceptance criteria and performance of the medical glove.

Acceptance Criteria and Device Performance for JR MEDIC Nitrile Examination Gloves Powder Free-Black

The device is a medical glove, and its performance is evaluated against established ASTM standards for physical properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes for each test. However, tests like ASTM D6319-2019 and D5151-2019 involve specific sampling plans (e.g., AQL for water tightness) where a number of gloves are sampled from a lot.
• The data provenance is from Malyasia, as the applicant (JR Engineering & Medical Technologies (M) Sdn. Bhd.) is located there. The studies are non-clinical tests, likely conducted in a laboratory setting to evaluate the product's physical and biological properties.

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)

• Not applicable. This is for a medical glove, not an AI/ML diagnostic device. Ground truth is established by objective measurements against industry standards (ASTM, ISO).

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

• Not applicable. This is for a medical glove, not an AI/ML diagnostic device requiring expert review and 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 for a medical glove, not an AI/ML device.

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

• Not applicable. This is for a medical glove, 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 the medical glove is based on established international and national standards (such as ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993 series). These standards define objective pass/fail criteria for physical properties and biocompatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

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