(76 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® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are 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.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005) |
| Meets ASTM D 5151-06 | |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility: | |
| ISO Skin Irritation Study | |
| ISO Maximization Sensitization Study - Extract | No irritation |
| No irritation |
The provided document is a 510(k) summary for medical gloves, and as such, it does not involve an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable.
Here's an analysis based on the information available for this medical device (examination gloves):
1. Table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005) & Meets ASTM D 5151-06 | Meets ASTM D 6319-00a(2005) & Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove | Powder content ≤ 2 mg per glove |
| Biocompatibility (ISO Skin Irritation Study) | No irritation | No irritation |
| Biocompatibility (ISO Maximization Sensitization Study - Extract) | No irritation | No irritation |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin but is based on performance tests against established ASTM and ISO standards for medical gloves. The tests are non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of medical device (examination gloves). Ground truth is established by adherence to physical and chemical standards and biocompatibility tests, not by expert consensus in the same way as an imaging or diagnostic AI/ML device would require.
4. Adjudication method for the test set
Not applicable. Testing involves standardized measurement and laboratory procedures, not human adjudication of performance in a diagnostic sense.
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, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on the specifications outlined in several ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for medical examination gloves. These are objective, measurable criteria and test methods. Specifically:
- ASTM D 6319-00a(2005): Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ISO standards for biocompatibility: (specific standard numbers not provided, but mentioned as "ISO Skin Irritation Study" and "ISO Maximization Sensitization Study - Extract").
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical product testing for medical gloves.
9. How the ground truth for the training set was established
Not applicable.
§ 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.