(49 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl Chloride) polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed as medical examination gloves. All requirements for physical properties and dimensions have been met for this intended use.
This document describes the safety and effectiveness of the Maxxim Medical SensiCare™ XP Vinyl Powder Free Medical Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM D 5250-99 & ASTM D 6124-97 & ISO10993-Part 10) | Reported Device Performance |
|---|---|
| Freedom from holes | Meets all ASTM D 5250-99 requirements |
| Physical properties | Meets all ASTM D 5250-99 requirements |
| Physical dimensions | Meets all ASTM D 5250-99 requirements |
| Non-irritating | Shown to be non-irritating |
| Non-sensitizing | Shown to be non-sensitizing |
| Powder-free labeling | Meets requirements of ASTM D 6124-97 for labeling as powder free (No powders utilized in manufacturing) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test. The tests were conducted in accordance with ASTM D 5250-99, ASTM D 6124-97, and ISO10993-Part 10. The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a physical product (medical examination gloves) undergoing testing for compliance with established material and safety standards. The "ground truth" is determined by standardized laboratory testing procedures and criteria outlined in the ASTM and ISO standards, not by expert human interpretation like in diagnostic imaging. Therefore, the concept of "experts establishing ground truth" in the way it applies to image analysis or clinical diagnosis is not applicable here.
4. Adjudication method for the test set:
Not applicable. The "adjudication method" as typically described for clinical or imaging studies (e.g., 2+1, 3+1) is not relevant for laboratory testing of physical product specifications against defined standards.
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 medical device (gloves), not an AI diagnostic or assistance tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
The ground truth used for proving the device meets the acceptance criteria is based on objective measurements and assessments against established scientific and industry standards. These standards include:
- ASTM D 5250-99: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard defines requirements for physical dimensions, tensile strength, elongation, and watertight integrity (freedom from holes).
- ASTM D 6124-97: Standard Test Method for Residual Powder on Medical Gloves. This standard defines the method for determining if gloves can be labeled as "powder-free."
- ISO 10993-Part 10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. This standard outlines procedures for assessing the potential of medical devices to cause irritation and sensitization.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
§ 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.