(51 days)
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
This document describes the acceptance criteria and performance of the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
The device, "Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol," is a medical examination glove. Its acceptance criteria and reported performance are based on its compliance with established ASTM standards and additional biocompatibility tests.
Acceptance Criteria and Reported Device Performance Table:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Physical Properties | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Freedom from Holes | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Meets ASTM D 5151-99 | Meets ASTM D 5151-99 | |
| Powder-Free | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Not more than 2 mg residue by mass per glove | Not more than 2 mg residue by mass per glove (implied by meeting ASTM standard) | |
| Biocompatibility | Primary Skin Irritation in Rabbits: Pass requirement | Passes |
| Guinea Pig Sensitization: Pass requirement | Passes |
Study Details for Device Performance
Based on the provided document, the device's performance is demonstrated through adherence to recognized industry standards, primarily ASTM D 3578-01a€2 and ASTM D 5151-99, along with specific biocompatibility tests.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes used for testing each characteristic (e.g., number of gloves tested for dimensions, holes, etc.).
- The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. However, the tests are performed to demonstrate compliance with ASTM standards, which are generally established protocols.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable to this type of device and study. The "ground truth" for glove performance is determined by established engineering specifications and chemical testing protocols outlined in the ASTM standards and biocompatibility tests, not by expert consensus on interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is determined by objective measurements against quantitative or qualitative pass/fail criteria defined by the ASTM standards and biocompatibility tests.
4. 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 not an AI/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (examination glove), not an algorithm. The performance is inherent to the product's physical and chemical properties.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on established engineering and material science specifications as defined in the ASTM standards (D 3578-01a€2 for general examination glove requirements, D 5151-99 for freedom from holes) and standardized biological testing protocols for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards specify the methods and criteria for determining whether the glove meets the necessary performance and safety requirements.
7. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of demonstrating compliance for such a product.
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The specifications used to design and manufacture the gloves would be based on the requirements of the ASTM standards, and their performance is verified through testing against those standards.
§ 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.