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A Pre-Powdered Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Patient Examination Gloves are a Class I device 21 CFR 880. These gloves are pre-powdered with a PMA approved Corn Starch Powder. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.

This document describes the acceptance criteria and the study conducted for the Safe Shield Pre-Powdered Latex Examination Gloves (K013980).

The device in question, a pre-powdered latex examination glove, is a Class I medical device, which typically does not require extensive clinical studies to demonstrate safety and effectiveness. Instead, substantial equivalence to a predicate device is shown through non-clinical performance testing against recognized standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The study for this device primarily involved non-clinical performance testing against established standards. The acceptance criteria are derived from ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves, as well as specific MIL-STD-105E AQLs. The document presents the physical specifications and properties as "minimums," implying these are the acceptance criteria, and the device is implied to meet or exceed these values.

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

• Sample Size: The document refers to sampling plans based on MIL-STD-105E, specifically "General Inspection Level G II, normal inspection and acceptable quality level of 4.0" for Pin Hole Testing, and "G-II" for Water Tight Test (AQL 2.5), and "S-2" for Dimensions and Physical Properties (AQL 4.0). However, the specific number of units tested (sample size in concrete numbers for each test) is not explicitly stated. MIL-STD-105E defines sample sizes based on lot size and inspection level, but these actual numbers are not provided in the summary.
• Data Provenance: The data is generated from tests performed by the manufacturer, Safe Shield Co. Ltd. The country of origin for the data generation would be Thailand, where the company is located. The testing is prospective in the sense that it's performed on newly manufactured devices to demonstrate compliance for regulatory submission.

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

Not Applicable. This device is a Class I glove, and its performance is assessed through objective physical and chemical testing against established standards (ASTM, FDA regulations, MIL-STD). There is no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The performance is determined by measurable physical properties.

4. Adjudication method for the test set

Not Applicable. As mentioned above, there's no human adjudication involved in determining the test results for physical properties of gloves. The tests are objective and follow standard protocols (e.g., water fill test, tensile strength measurement).

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 physical device (examination glove), not an AI software. Therefore, an MRMC study or any assessment of AI assistance is irrelevant.

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

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, measurable physical properties defined by:

• ASTM 3578-00 standard for latex examination gloves,
• Food and Drug Administration (FDA) requirements for Patient Examination Gloves (including the 1000 ml Water fill test described in 21 CFR 800.20), and
• MIL-STD-105E for sampling and acceptable quality levels (AQLs).

These are established industry and regulatory standards for glove quality.

8. The sample size for the training set

Not Applicable. "Training set" is a concept typically used for AI/machine learning models. This device is a physical product and does not involve any machine learning for its function or performance assessment. Its manufacturing process would be subject to quality control, but not a "training set" in the computational sense.

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

Not Applicable. See point 8.

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A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.

The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.

The provided text describes the acceptance criteria and the methods used to demonstrate substantial equivalence for the "Safe Shield Powder-Free Latex Examination Gloves." Since this is a medical device (gloves), the "performance" metrics relate to physical properties and barrier integrity rather than a complex AI algorithm's diagnostic accuracy. Therefore, several points in your requested output (like MRMC studies, effect size of AI assistance, expert qualifications, etc.) are not applicable in this context.

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

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

Note: The text states "The physical specifications are as follows:" and then lists specific values for length, thickness, width, tensile strength, and ultimate elongation. These values are presented as minimums or exact specifications which the device must meet. The table above assumes the device met these exact listed values to claim substantial equivalence.

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

• Sample Size: The text refers to "Sampling and AQLs" for the Water Tight Test and Dimensions. For the Water Tight Test, it specifies "G-II" general inspection level and for Dimensions it specifies "S-2" special inspection level, derived from MIL-STD-105E. However, the exact number of units sampled for these tests is not explicitly stated in the provided text, only the inspection levels and AQLs.
• Data Provenance: The text does not provide information about the country of origin of the data or whether the tests were retrospective or prospective. It implies the performance testing was conducted by Safe Shield Co. Ltd. in Thailand.

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 device is a physical barrier protection device (gloves), not an diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for gloves is adherence to physical performance specifications and barrier integrity.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies, often involving expert readers. This is not relevant for the physical testing of examination gloves.

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-assisted diagnostic tool. No MRMC study was conducted or is 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 algorithm.

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

The "ground truth" for this device is established by conformance to recognized standards and regulatory requirements for physical properties and barrier integrity.

• Physical dimensions and properties: Based on ASTM 3578-00.
• Pin hole testing (water tightness): Based on the FDA's "1000 ml Water fill test method" as described in 21 CFR 800.20, with sampling derived from MIL-STD-105E.

8. The sample size for the training set

Not applicable. There is no "training set" for physical testing of medical gloves. This term typically refers to data used to train machine learning models.

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

Not applicable, as there is no training set for this type of device.

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