(99 days)
The Halyard® Black-Orange 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.
Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable, black-colored on the grip side and orange colored on the donning side, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are chlorinated on the donning side and are packed in a cardboard dispenser box.
The document describes the testing performed for the Halyard® Black-Orange Powder-Free Nitrile Exam Glove to demonstrate its substantial equivalence to a predicate device. This is not a study about an AI-powered device, but rather a medical device (exam glove) being evaluated against established standards. Therefore, some of the requested information regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance) is not applicable.
Here's the information that can be extracted from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves | Meets the 2.5 AQL requirement in the standards 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. PASS" |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications | Holes: AQL 2.5% | |
| Length: ≥230 mm | ||
| Width: 85-105mm | ||
| Finger thickness: ≥0.050mm | ||
| Palm thickness: ≥0.050mm | ||
| Unaged Tensile: ≥14 MPa | ||
| Unaged Elongation: ≥500% | ||
| Aged Tensile: ≥14 MPa | ||
| Aged Elongation: ≥400% | ||
| Powder: ≤2mg/glove | Holes: AQL 1.0% | |
| Length: 230-258 mm | ||
| Width: 85-105mm | ||
| Finger thickness: 0.06-0.09mm | ||
| Palm thickness: 0.05-0.07mm | ||
| Unaged Tensile: ≥16 MPa | ||
| Unaged Elongation: ≥500% | ||
| Aged Tensile: ≥15 MPa | ||
| Aged Elongation: ≥450% | ||
| Powder: ≤2mg/glove | ||
| "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. PASS" | ||
| ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.