(87 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the "NON-STERILE POWDER FREE BLUE NITRILE EXAMINATION GLOVES WITH VANILLA SCENTING," a patient examination glove. The provided text outlines the device's classification, intended use, and its equivalence to a predicate device, but it lacks detailed information regarding specific performance acceptance criteria and study data typical for AI/ML device evaluations.
Therefore, for aspects related to AI/ML device evaluation, the information is not available in the provided text. The following describes the available information focused on the
glove's conformity to standards.
Acceptance Criteria and Device Performance for Powder-Free Blue Nitrile Examination Gloves with Vanilla Scenting
The acceptance criteria for this device are based on its conformity to recognized industry standards for patient examination gloves. The performance of the device is reported as meeting these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application | Device meets all requirements of ASTM-D6319-00aE1 |
| Powder-Free | Confirmed to be powder-free |
| Non-Sterile | Confirmed to be non-sterile |
| Patient examination glove (per 21 CFR 880.6250) intended for medical applications | Confirmed for intended use |
2. Sample Size and Data Provenance for the Test Set
The provided summary does not detail a specific "test set" in the context of sampling a batch of gloves for evaluation. Instead, the device's performance is stated as meeting the requirements of a recognized standard, ASTM-D6319-00aE1. This standard outlines various tests (e.g., physical properties, barrier integrity) that examination gloves must pass. The glove manufacturer is responsible for ensuring ongoing compliance through their quality system, which would involve sampling and testing according to the standard's guidelines. The document does not specify the country of origin of the data or whether the data is retrospective or prospective, as it implicitly refers to adherence to a standard rather than a specific study.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. For examination gloves, "ground truth" is established by adherence to specified physical and chemical properties defined in standards like ASTM-D6319-00aE1, rather than through expert consensus on diagnostic images or clinical outcomes. The experts would be professionals in materials testing, quality control, and regulatory compliance who ensure the manufacturing process and product meet the standard's specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjectively assessed data, such as medical image interpretation, to resolve discrepancies among experts. For glove performance, objective measurements against technical specifications dictate acceptance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the effectiveness of a diagnostic tool, such as how AI assistance improves human interpretation of medical images. This device is a medical glove, not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. This device is a physical medical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective measurements against established technical specifications and performance criteria outlined in the ASTM-D6319-00aE1 standard. This includes physical properties (e.g., tensile strength, elongation), dimensions, and barrier integrity (e.g., pinhole detection). It does not involve expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices.
8. Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This product is a medical glove, manufactured according to established processes and tested against standards. There is no AI model or training involved in its development as described.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons mentioned in point 8.
§ 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.