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

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.

The provided document describes the FDA 510(k) premarket notification for "Latex Examination Powder Free Gloves." This is a Class I medical device, which typically does not require a complex AI/algorithm-based study with human readers, ground truth establishment by experts, or MRMC studies. The approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance data against established industry standards.

Therefore, many of the requested elements for describing AI acceptance criteria and study methodology (like sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of device and submission.

The document explicitly states "H. SUMMARY OF CLINICAL TESTING: Not applicable." This reinforces that the submission did not rely on clinical performance data involving human readers or sophisticated AI algorithms.

However, I can extract the acceptance criteria and performance data as presented for these gloves.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Latex Examination Powder Free Gloves" are based on established ASTM (American Society for Testing and Materials) standards for rubber examination gloves. The table below summarizes these criteria and the reported performance of the device (K222348) compared to the predicate device (K192329).

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this Device Type)

Given this is a 510(k) for examination gloves, the "study" is a series of non-clinical, laboratory tests performed according to specific ASTM and ISO standards, rather than a clinical trial or an AI algorithm performance study.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, width, or tensile strength). However, it implies that standard testing methodologies as defined by ASTM and ISO were followed. These standards usually specify the number of samples required for each test. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., Malaysia, indicating the tests were conducted by the manufacturer or a contracted lab in Malaysia. The data is non-clinical performance data, reported as part of a premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device is physical and chemical adherence to specific measurable standards (e.g., a glove is X mm long, has Y tensile strength), not a diagnostic interpretation requiring expert medical opinion. The standards themselves, like ASTM D3578-2019, serve as the "ground truth" for performance.

4. Adjudication Method for the Test Set:
Not applicable. This is not a human-interpreted diagnostic task requiring adjudication. The tests are objective measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not done. MRMC studies are typically for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) on clinical cases is evaluated. This device is an examination glove.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm. Its performance is measured through physical and chemical properties.

7. The Type of Ground Truth Used:
The ground truth used is objective engineering and material science standards (e.g., ASTM D3578-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-95, ISO 10993 series). These are internationally recognized standards for manufacturing and safety.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI device trained on a dataset. The "training" for such a device would be the manufacturing process development and quality control to ensure consistency.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as it's not an AI training set. The "ground truth" for manufacturing would be the specifications and quality control procedures adherence to ensure gloves meet the physical and chemical standards.

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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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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.

JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) 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 available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.

This document describes the premarket notification (510k) for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against established standards and a predicate device, rather than a clinical study with human subjects, AI algorithms, or ground truth established by experts.

Here's an analysis of the provided text in relation to your questions:

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

The document provides extensive tables detailing the acceptance criteria (standards) and the device's performance for both the orange and purple gloves. Below is a consolidated table with key physical, chemical, and biological performance characteristics.

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 does not explicitly state the sample sizes used for each specific test. However, the tests are adherence to ASTM and ISO standards, which define the sample sizes and methodology for such testing. For example, ASTM D5151-2019 (Watertightness) involves sampling a number of gloves from a lot to determine AQL (Acceptance Quality Limit). The testing presumably took place in Malaysia, where the manufacturer is located. The nature of these tests (e.g., physical property measurements, biocompatibility) suggests they are prospective, as new gloves are being manufactured and tested to ensure they meet specifications.

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 a diagnostic AI device requiring expert interpretation of medical images or data. The "ground truth" for the test set is established by the specifications defined in the relevant ASTM and ISO standards for physical, chemical, and biological properties of examination gloves. Therefore, there are no "experts" in the sense of radiologists or clinicians establishing ground truth for the test set. The validation relies on standard laboratory testing procedures performed by qualified technicians/laboratories.

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

Not applicable. This is not a study involving human readers or interpretation of complex data where adjudication would be necessary. The testing involves objective measurements against predefined criteria.

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 not an AI/software device or a diagnostic tool that involves human readers. It is a physical medical device (examination gloves).

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

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

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

The "ground truth" in this context is based on standardized test methods and specifications (ASTM and ISO standards). For example:

• Physical Property Ground Truth: Defined by acceptable ranges for length, width, thickness, tensile strength, and elongation as per ASTM D6319-2019.
• Watertightness Ground Truth: Defined by an Acceptance Quality Limit (AQL) as per ASTM D5151-2019.
• Chemical Property Ground Truth: Defined by maximum allowable powder residue as per ASTM D6124-06.
• Biocompatibility Ground Truth: Defined by the absence of irritation, sensitization, or systemic toxicity as per ISO 10993 series, and a determination regarding cytotoxicity.

8. The sample size for the training set

Not applicable. As this is a traditional medical device (gloves) and not an AI/machine learning model, 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 this type of device submission.

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JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes

Warning: Do not use with Carmustine or Thiotepa.

The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).

The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

The provided document describes the safety and performance testing of "JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs" to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets general acceptance criteria for a new medical device technology like an AI algorithm.

Therefore, the requested information elements related to AI/algorithm performance, such as sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set are not applicable to this document.

The document focuses on the physical, chemical, and biological properties of examining gloves and their resistance to chemotherapy drugs.

However, I can extract the acceptance criteria and reported device performance from the provided "G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section, focusing on the glove's performance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

Non-Applicable Information for this Document:

The following requested information is not applicable to the provided document as it describes the FDA 510(k) clearance for examination gloves and their resistance to chemotherapy drugs, which is a physical device, not an AI/algorithm-based diagnostic or therapeutic tool.

2. Sample size used for the test set and the data provenance: Not applicable - tests are on gloves, not a data set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable - "ground truth" concept does not apply in this context; instead, it's about objective physical/chemical measurements and biological responses.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.

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 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)

I am sorry, but the provided text does not describe a study involving an AI device or algorithm, and therefore all the requested information about acceptance criteria, study design, sample sizes, ground truth, expert involvement, and MRMC studies cannot be extracted.

The document is a 510(k) premarket notification for "JR Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs." It details the non-clinical testing performed on these medical gloves to demonstrate their safety and effectiveness, specifically their resistance to permeation by chemotherapy drugs, in accordance with established ASTM (American Society for Testing and Materials) standards.

The document focuses on the physical, chemical, and biocompatibility properties of the gloves, not on the performance of a software algorithm or AI.

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