(113 days)
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
The acceptance criteria and reported device performance for the Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are detailed below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Physical Properties | ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | ASTM D 6319-00a(2005) and ASTM D 5151-06 | Meets ASTM D 6319-00a(2005) and Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove | Powder content ≤ 2 mg per glove |
| Biocompatibility: | ||
| ISO Skin Irritation Study | Passes | Passes |
| ISO Maximization Sensitization Study - Extract | Passes | Passes |
| Cytotoxicity Study Using the End-Point Titration Method | Non-toxic at 24 hrs. for dilutions 1:2 through 1:32 | Non-toxic at 24 hrs. for dilutions 1:2 through 1:32 |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the test sets for each characteristic. The performance data is presented as meeting specific ASTM standards or defined criteria (e.g., powder content, biocompatibility outcomes). The data provenance is not specified, but it can be inferred that these are standard in-house or contract lab tests performed to confirm compliance with regulatory and standard requirements. The tests are non-clinical ([8]).
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. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not against "ground truth" established by experts in the context of diagnostic interpretation. The evaluation relies on laboratory testing and measurements.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. Performance is measured against objective standards, not subjective interpretations requiring 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 as the device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical glove, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by conformance to recognized industry standards (ASTM) and accepted biological testing protocols (ISO). For example:
- Physical properties (dimensions, tensile strength) are "true" if they fall within the specified ranges of ASTM D 6319-00a(2005).
- Freedom from holes is "true" if it meets the criteria of ASTM D 6319-00a(2005) and ASTM D 5151-06.
- Biocompatibility is "true" if the tests (ISO Skin Irritation, ISO Maximization Sensitization, Cytotoxicity) yield "Passes" or "Non-toxic" results as defined.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this 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.