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The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.

The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.

There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.

The materials and the manufacturing process technology are the same.

The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for a test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How the ground truth for an AI/ML training set was established.

However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.

Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves

This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):

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

• The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
• Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."

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

• This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.

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

• Not applicable for this type of device testing.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
• For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
• For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.

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

• Not applicable as this is not an AI/ML device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):

Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).

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

• The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
• Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.

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 device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.

4. Adjudication method for the test set:

• This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations requiring 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 device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.

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

• The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
  • For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
  • For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
  • For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.

8. The sample size for the training set:

• This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

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

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes = Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a Class I medical device, which means it is subject to general controls and does not require approval of a premarket approval application (PMA). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K192954).

The acceptance criteria and study proving the device meets these criteria are based on non-clinical performance data, as no clinical performance data was provided or required for this device type.

Acceptance Criteria and Device Performance Study

The device's performance was evaluated against various ASTM and ISO standards for medical examination gloves, particularly focusing on their physical properties and resistance to permeation by chemotherapy drugs and Fentanyl Citrate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for water leaks, chemical permeation). However, the tests were conducted according to established industry standards such as ASTM and ISO, which typically define appropriate sample sizes for such evaluations.

The data provenance is based on non-clinical laboratory testing performed by or for Better Care Plastic Technology Co., Ltd. The owner's identification indicates their address as "Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China," suggesting the tests took place in China. The data is retrospective in the sense that it represents completed laboratory tests submitted for the 510(k) application.

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

This information is not explicitly provided in the document. For non-clinical validation of gloves, "ground truth" is typically established by adherence to established test methodologies (ASTM, ISO standards) and the measured physical/chemical properties, rather than expert consensus on subjective evaluations. The "experts" would be the certified laboratories and technicians performing these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the validation involves standardized physical and chemical property testing, not subjective human evaluation requiring 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 diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This document pertains to physical medical devices (examination gloves), for which MRMC studies are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable to a physical medical device like an examination glove. The "performance" being evaluated is the glove's physical and chemicalbarrier properties, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM D6319-19 for physical dimensions, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the acceptable range or threshold for a given property.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (nitrile gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for a physical device.

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

Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. 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 document provided describes the acceptance criteria and performance data for a Powder Free Nitrile Examination Glove (Blue), K220284, in comparison to a predicate device. This is a medical device submission, and the studies described are non-clinical performance data to demonstrate substantial equivalence, not studies related to AI or diagnostic algorithms. Therefore, many of the requested fields related to AI/algorithm performance (e.g., MRMC studies, standalone performance, training set details) are not applicable.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.

Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs." This is a Class I medical device, and the testing focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. It is crucial to note that this document pertains to a physical medical device (gloves) and not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI/SaMD specific aspects like expert data labeling, MRMC studies, training set data, etc., are not applicable to this submission. The information provided aligns with typical performance testing for physical devices.

Here's the breakdown of the acceptance criteria and reported performance, tailored to the available information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

Regarding the AI/SaMD specific questions, the following points are not applicable as this document describes performance testing for a physical medical glove.

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 specify the exact sample sizes for each physical test (e.g., how many gloves were tested for tensile strength, or how many samples for biocompatibility). Standard test methods (ASTM, ISO) typically define minimum sample sizes. The data provenance is implied to be from testing labs in relation to the manufacturer (Shanxi Hongjin Plastic Technology Co., Ltd. in China) and their US representative. This is a prospective testing of the manufactured product.

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. Ground truth for physical device performance is established by standardized laboratory testing methods (ASTM, ISO) rather than expert human interpretation.

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

• Not applicable. Adjudication methods are typically relevant for human-in-the-loop assessments or expert consensus in image interpretation, not for physical material testing.

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/SaMD.

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

• Not applicable. This is not an AI/SaMD. The "standalone" performance here refers to the physical properties 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 objective measurements derived from standardized testing protocols (ASTM and ISO standards) measuring physical properties (like length, thickness, tensile strength, freedom from holes, powder content) and chemical resistance (breakthrough time for chemotherapy drugs), as well as biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

• Not applicable. This is not an AI/SaMD, so 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 physical device testing, there is no ground truth establishment method for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international (ISO) and national (ASTM) standards. These tests assess the physical, chemical, and biological properties of the nitrile examination gloves.

The "Non-Clinical Performance Data" section (Page 9 of the document) explicitly lists the test methods used, their purpose, the acceptance criteria, and the results, confirming that the proposed device complies with these standards. For example, ASTM D6319-19 was used for dimensions and tensile properties, ASTM D5151-19 for freedom from holes, ASTM D6124-06 for powder content, and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Biocompatibility was assessed using ISO 10993 series standards (Parts 5, 10, and 11) for cytotoxicity, irritation, sensitization, and systemic toxicity.

The conclusion states, "The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device." This indicates that the results met the established benchmarks (which are often derived from the requirements of the standards themselves or comparison to a predicate device).

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

The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) Pre-market Notification for Powder Free Nitrile Examination Gloves (Blue). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on product safety and effectiveness standards rather than complex AI algorithm performance.

Therefore, the requested information pertaining to AI algorithm studies (sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this device.

The study described in this document is a non-clinical performance evaluation to demonstrate adherence to established medical device standards.

Here's the relevant information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, pinholes, etc.).
• The data provenance is implied to be from tests conducted on the manufacturer's product, Nam Viet Glove Joint Stock Company in Vietnam. The description of tests being performed on "the test article" implies prospective testing.

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 medical device (examination gloves), "ground truth" is established by adherence to physical and chemical standards and test methods outlined by organizations like ASTM and ISO, not human expert consensus on interpretations. The results are objective measurements.

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

• Not Applicable. As mentioned above, the tests involve objective measurements against predefined standards, not subjective interpretations requiring 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 device is a physical product (nitrile gloves), not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is a physical product, not an algorithm.

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

• The "ground truth" is defined by the objective specifications and quantifiable limits set by international standards (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-06) and FDA regulations (21 CFR 800.20). Performance is measured directly against these specified values.

8. The sample size for the training set:

• Not Applicable. This applies to AI/machine learning models which are not relevant here.

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

• Not Applicable. This applies to AI/machine learning models which are not relevant here.

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