(57 days)
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Nitra-Touch™ Sterile examination gloves are disposable device 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 the study results for the Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove by Ansell Perry.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319 | Meets ASTM D 6319 |
| Physical Properties: | ||
| Tensile Strength, minimum | Meets ASTM D 6319 (14 MPa) | Exceeds ASTM D 6319 (14 MPa) |
| Freedom from holes | Meets ASTM D 6319, Meets ASTM D 5151 | Meets ASTM D 6319, Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass, Meets ASTM D 6124 | Not more than 2 mg residue by mass, Meets ASTM D 6124 |
| Biocompatibility | ||
| Primary Skin Irritation (Rabbits) | Acceptable (Passes) | Passes |
| Guinea Pig Sensitization | Acceptable (Passes) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., for dimensions, tensile strength, freedom from holes, powder-free, or biocompatibility). However, it indicates that the tests were conducted according to established ASTM standards (D 6319, D 5151, D 6124). These standards often prescribe minimum sample sizes for testing.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are "non-clinical tests" conducted to demonstrate conformity with recognized standards like ASTM, which are generally performed in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "ground truth" for medical examination gloves is established by objective, quantifiable measurements against defined performance standards (ASTM standards) and biocompatibility tests, rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set
This information is not applicable. The performance is measured against objective standards, not through subjective adjudication.
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
This information is not applicable. This device is a medical examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for evaluating the Nitra-Touch™ gloves is defined by:
- Established Industry Standards: ASTM Standard D 6319 (Nitrile Examination Gloves for Medical Application), ASTM D 5151 (Freedom from Holes), and ASTM D 6124 (Powder Residue).
- Biocompatibility Test Pass/Fail Criteria: Standard methods for assessing Primary Skin Irritation and Guinea Pig Sensitization.
- FDA Hole Requirements: The gloves also meet FDA hole requirements.
These ground truths are objective and quantitatively measurable.
8. The sample size for the training set
This information is not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These products are manufactured and then tested for compliance with specifications.
9. How the ground truth for the training set was established
This information is not applicable, as 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.