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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).

The subject device in this 510(k) Notification is Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate, Powder Free & Non sterile Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves & ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The available sizes of the subject devices are Small, Medium, Large, X-Large.

The provided text describes the acceptance criteria and the study that proves the device (Iconic Blue Nitrile Glove) meets them. Here's a breakdown of the requested information:

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 specify the exact sample size for each test conducted but references standards like ASTM D6319-19 for physical properties, which would imply a specific sampling plan within that standard (e.g., AQL 2.5, AQL 4.0 inspection level S-2). For chemotherapy drug permeation, three specimens were tested for each drug, as indicated by "Minimum Breakthrough Detection Time (Specimen 1,2,3)".

The data provenance is not explicitly stated in terms of country of origin. The studies are non-clinical (laboratory tests) and are retrospective in the sense that they were performed to demonstrate compliance with existing standards.

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

This section is not applicable. The evaluations are based on standardized laboratory tests (e.g., ASTM, ISO standards) rather than expert interpretation of medical images or patient data. The "ground truth" is determined by measurements against predefined quantitative criteria and methodologies outlined in these standards.

4. Adjudication method for the test set

This section is not applicable as the tests are objective, quantitative measurements against established standards. There is no subjective interpretation requiring expert adjudication.

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

This section is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool or an imaging system. Therefore, MRMC studies are not relevant to its evaluation.

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

This section is not applicable. The device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through material and chemical resistance tests.

7. The type of ground truth used

The ground truth used for these studies is based on standardized, objective measures and methodologies defined by established industry and regulatory standards, including:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application (for physical properties like dimensions, tensile strength, elongation).
• ASTM D5151-19: Standard for Freedom from hole (pinholes).
• ASTM D6124-06: Standard for Residual Powder.
• ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical breakthrough times).
• ISO 10993-5 (Biological evaluation of medical devices - Part 5): Tests for in vitro cytotoxicity.
• ISO 10993-10 (Biological evaluation of medical devices - Part 10): Tests for irritation and skin sensitization.
• ISO 10993-11 (Biological evaluation of medical devices - Part 11): Tests for systemic toxicity.

The "ground truth" is the result of these specific test procedures and direct measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This section is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the context of AI or algorithms.

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

This section is not applicable for the reasons stated above (not an AI/ML device).

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This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.

The information provided describes the acceptance criteria and the study conducted for the Iconic Latex Glove, a non-powdered patient examination glove.

Here's a breakdown of the requested information:

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 specify the exact sample sizes used for each individual test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only provides the average results for different glove sizes (Small, Medium, Large, X-Large). The data provenance is not explicitly stated beyond the fact that the tests were conducted by a company in Malaysia (Iconic Medicare Sdn Bhd is in Malaysia, and the general testing information implies this is where their reports originated). These appear to be retrospective tests conducted on manufactured batches of the device.

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, and the "ground truth" is established through standardized laboratory testing against international and national standards (ASTM, ISO). There are no "experts" in the sense of clinicians or radiologists establishing ground truth.

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for interpreting results (e.g., medical images) where human judgment is involved in establishing a diagnosis or reading. The tests performed for this device are objective measurements against defined acceptance criteria in laboratory settings.

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 medical glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic performance with and without AI assistance.

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

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

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

The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory tests according to recognized national and international standards (ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712 -15, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021).

8. The sample size for the training set

This is not applicable. The device is a physical product (a glove), not a machine learning model that requires a training set.

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

This is not applicable (see point 8).

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This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.

The provided text describes the acceptance criteria and the results of a study for the "Iconic Nitrile Glove," a non-powdered patient examination glove.

Here's the breakdown of the requested information:

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 sample size for each test (e.g., how many gloves were tested for pinholes, or how many samples for biocompatibility). However, it refers to standard methodologies like ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, and ISO 10993 series, which inherently define sample sizes for achieving statistical significance. The data provenance is not specified beyond the fact that the tests were conducted for "Iconic Medicare Sdn Bhd" located in Malaysia. It is a non-clinical, laboratory-based testing scenario.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For this type of device (nitrile gloves), the ground truth is established through adherence to standardized international test methods (ASTM and ISO standards) and their specific acceptance criteria, rather than expert consensus on subjective observations.

4. Adjudication method for the test set
Not applicable. As the ground truth is based on quantitative measurements and adherence to specified standard criteria, no human adjudication method (like 2+1 or 3+1) is mentioned or implied.

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 nitrile glove, not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a nitrile glove, not an algorithm.

7. The type of ground truth used
The ground truth is established by adherence to internationally recognized standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23) which define specific physical, mechanical, and biological properties and their acceptance limits.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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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