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The Halyard ® Fusion Black Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are chlorinated on the donning side and are packed in a cardboard dispenser box.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Halyard® Fusion Black Powder-Free Nitrile Exam Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Standard	Acceptance Criteria	Reported Device Performance
ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves	Meets the 2.5 AQL (Acceptable Quality Level) requirement for leakage.	Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications	Physical dimensions are within the standard limits. Physical properties (tensile strength and elongation) meet the standard requirements.	The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore, the device meets the acceptance criteria of the standard.
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves	Residual powder is within the powder-free limit of < 2 mg maximum powder per glove.	Residual powder on the subject device is within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free.
ISO 10993-10 Biological evaluation of medical devices - Tests for Irritation	Erythema/edema up to 72 hours post exposure. (Implicitly, the criteria is for negligible erythema/edema based on the result.)	Erythema/edema was negligible. Meets acceptance criteria.
ISO 10993-10 Biological evaluation of medical devices - Tests for Skin Sensitization	No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection.	Not a sensitizer under conditions of the study. Meets acceptance criteria.
ISO 10993 Biological evaluation of medical devices - Tests for Systemic Toxicity	No signs of systemic toxicity up to 72 hours post injection.	No systemic toxicity observed. Meets acceptance criteria.

Study Information:

The provided document describes a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than a de novo clinical study proving novel performance. The "study" here refers to the testing conducted to show the device meets recognized standards.

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

The document does not explicitly state the sample sizes used for the individual tests (ASTM D5151, D6319, D6124, ISO 10993 series). It only implies that "testing of the subject device" was performed.

The data provenance is not specified in terms of country of origin. The data is presented as retrospective in the sense that these tests were conducted on the device to demonstrate compliance with established standards for a premarket submission.

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

This information is not applicable in the context of this submission. The "ground truth" for medical exam gloves typically refers to their physical properties and biocompatibility, which are assessed objectively through standardized laboratory tests, not through expert consensus on diagnostic images or clinical outcomes. The "experts" would be the personnel conducting and interpreting the standardized laboratory tests, whose qualifications are governed by the respective test methodologies and good laboratory practices.

4. Adjudication Method for the Test Set:

This is not applicable. As these are objective laboratory tests against defined numerical or qualitative criteria in recognized standards, there is no need for an adjudication method among experts. The results are either within spec or out of spec.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, with and without AI assistance, to assess improvements in performance. Medical exam gloves do not involve human interpretation in this manner.

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

No, a standalone (algorithm only) performance study was not done in the context of AI. This device is a physical medical exam glove, not an algorithm or AI system. The performance is assessed through its physical and biological properties.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and regulatory requirements for the physical, chemical, and biological properties of medical exam gloves. These include:

Quantitative measurements: For dimensions, tensile strength, elongation, and residual powder.
Qualitative and semi-quantitative assessments: For leakage (AQL), irritation (erythema/edema), skin sensitization, and systemic toxicity.
These are based on the criteria defined within ASTM and ISO standards.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As stated above, there is no training set involved for this type of device.

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