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This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.

Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the current specifications of ASTM D6319-00a(2005)e1, Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance of "Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs" as part of a 510(k) submission (K093523).

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Chemotherapy Drug Permeation Acceptance Criteria: While specific minimum breakthrough times are not explicitly listed as "acceptance criteria" in the table within the document, the "Indications for Use" section presents these values as the performance data for which the device was "tested for use." The underlying acceptance criterion for these drugs would be defined by the ASTM D6978-05 standard for acceptable permeation, likely implying a desired "resistant" or "protective" duration, which the ">240 minutes" results aim to demonstrate. The WARNING regarding Carmustine and ThioTEPA with their lower breakthrough times indicates that these specific drugs do not meet an acceptable level of protection, hence the cautionary instruction.

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

The document does not specify the exact sample sizes (e.g., number of gloves tested) for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility, and Chemotherapy Drug Permeation). It only reports the performance results based on standard test methods.

The data provenance is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective. However, given that this is a 510(k) submission for a new device, the testing would generally be considered prospective in nature, performed specifically for regulatory submission.

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

There is no mention of experts being used to establish a "ground truth" in the context of interpretation or diagnosis for this device. This product is a physical device (examination gloves), and its performance is evaluated through standardized laboratory tests, not through expert review of clinical images or data. Therefore, the concept of qualified experts establishing ground truth for a test set is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the performance of the gloves is based on objective laboratory measurements and adherence to ASTM standards, not on subjective assessment requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an imaging or diagnostic device that would typically involve human readers or MRMC studies. The device is a medical glove, and its effectiveness is determined by its physical and chemical barrier properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The testing performed for the gloves is entirely "standalone" in that it evaluates the intrinsic properties of the device itself (e.g., integrity, dimensions, chemical resistance) without human interaction or a "human-in-the-loop" component for its functional assessment. There is no algorithm involved.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Standardized Test Methods and Specifications: Adherence to defined ASTM standards (e.g., ASTM D 6319-00a(2005)e1 for dimensions and physical properties, ASTM D 5151-06 for freedom from holes, ASTM D 6124-06 for powder residue, and ASTM D6978-05 for chemotherapy drug permeation).
• Established Biological Safety Standards: Demonstrated biocompatibility through "Animal Study" results (Primary Skin Irritation and Dermal Sensitization Assay).

These standards and test results serve as the objective "truth" against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a diagnostic system that learns from data.

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

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

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Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Here's a breakdown of the acceptance criteria and the study details for the "Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves," based on the provided document:

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 sample size used for each specific test within ASTM D 6319-00 or ASTM D 5151-99. These are standardized tests, and the sample sizes are dictated by the respective ASTM standards themselves. The data provenance is not specified beyond being generated by Ansell Healthcare Products Inc., implicitly in the USA. The data would be considered prospective as it's generated specifically for the clearance of this device.

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

This information is not provided in the document. For these types of medical devices (gloves), the "ground truth" is typically established by physical and chemical testing against recognized industry standards (ASTM standards), rather than by expert consensus on observational data. The standards themselves define the acceptable parameters.

4. Adjudication Method for the Test Set

This information is not applicable in the context of these physical and chemical tests. The "ground truth" is determined objectively by the test results themselves against the pre-defined criteria in the ASTM standards. There is no need for human adjudication of test results in the way it might be applied to image interpretation or clinical outcomes.

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 not relevant for medical examination gloves which are evaluated based on their physical properties, freedom from holes, and biocompatibility, not on interpretive clinical judgments by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This device is a physical product (medical glove), not an algorithm or AI system. Therefore, the concept of "algorithm only" performance is not applicable.

7. The Type of Ground Truth Used

The ground truth used is primarily objective measurements against established industry standards (ASTM D 6319-00 and ASTM D 5151-99), along with biocompatibility test results.

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device and not an AI or machine learning model, there is no "training set."

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

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

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