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The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.

Powder Free Nitrile Examination Gloves (Blue, Purple-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, 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 provided document describes the acceptance criteria and results of non-clinical testing for "Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K240072). This is a physical medical device (gloves), not an AI/ML powered device. Therefore, questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, sample size for training sets, number of experts for ground truth, adjudication methods) are not applicable.

Here's the relevant information from the document:

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

Breakthrough Detection Time (BDT) for Chemotherapy Drugs and Fentanyl Citrate:

Please refer to the tables provided in pages 3, 4, 7, and 8 of the document for the detailed BDT for each specific chemotherapy drug and Fentanyl Citrate for both Blue and Purple-Blue gloves. The general acceptance criterion implied is that the gloves provide a certain level of protection (BDT), and the performance reports these measured BDTs. Notably, for Carmustine and Thiotepa, the BDTs are explicitly called out as "extremely low permeation times" with a warning not to use them with these drugs.

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 for each specific non-clinical test (e.g., number of gloves tested for physical dimensions, chemotherapy permeation, etc.). However, these tests are generally conducted by manufacturers according to standardized protocols (e.g., ASTM standards) which define the required sample sizes for each test. The provenance specific to the data (e.g., country of origin, retrospective/prospective) is not detailed for these non-clinical bench tests. These are laboratory tests on the product itself.

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 a physical device submission (nitrile examination gloves) and not an AI/ML-powered device that would require expert-established ground truth from medical imaging or similar data. The acceptance criteria are based on defined physical and chemical properties measured through standardized bench tests.

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

Not applicable. Adjudication methods are typically associated with human review of data, especially in clinical or AI/ML studies, to establish ground truth. This document pertains to non-clinical bench testing of a physical 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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device is established through performance against recognized industry standards (e.g., ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series). These standards define objective, measurable physical, chemical, and biological properties of the gloves. For example, breakthrough detection time for chemotherapy drugs is a direct measurement based on established laboratory procedures.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of AI/ML.

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

Not applicable. There is no training set for this physical device.

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Powder Free Nitrile Examination Gloves (Blue, Purple-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, Purple-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, Extra Large and XXL.

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).

This is an evaluation of Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are presented in the following table, derived from the "510(K) SUMMARY" (pages 11-12 of the document).

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

The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., for physical properties, biocompatibility, or chemotherapy drug permeation). It mentions that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" (page 11).

The data provenance is not explicitly stated in terms of country of origin for the testing data or whether it was retrospective or prospective. However, the manufacturer is Luliang Hongruida Health Protection Technology Co., Ltd. (China), and the "510(K) Summary" indicates that the testing was performed to verify the device's compliance with established international and US standards (ASTM, ISO). This suggests the testing was performed specifically for the purpose of this submission (prospective in that sense).

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

Not applicable. This submission is for medical gloves and involves non-clinical performance testing against established standards (e.g., ASTM, ISO), which do not typically require expert consensus for ground truth establishment in the way AI/CADe devices do. The "ground truth" is defined by the technical specifications of the standards themselves (e.g., a specific tensile strength value, acceptable limits for holes, or breakthrough time metrics).

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

Not applicable. As noted above, this device does not involve a diagnostic or interpretive task that would require human expert adjudication. The tests performed are objective measurements against defined 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 a medical glove, a physical device, not an AI/CADe system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

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

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

For the physical and chemical properties (e.g., tensile strength, freedom from holes, powder content, biocompatibility, chemotherapy drug permeation), the "ground truth" is established by the specified test methods and their defined acceptance criteria (e.g., ASTM D6319-19, ASTM D6978-05, ISO 10993 series). These are objective, measurable standards, not subject to subjective interpretation or expert consensus in the typical sense of medical image analysis. For chemotherapy drug permeation, the "ground truth" is the measured breakthrough time for each drug using the ASTM D6978-05 standard.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set. The performance data is derived from specific tests on samples of the manufactured gloves.

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

Not applicable. As there is no training set for a physical device, no ground truth was established for it.

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