(28 days)
Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Here's a breakdown of the acceptance criteria and the study details for the "Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves," based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319-00 | Meets ASTM D 6319-00 |
| Physical Properties | Meets ASTM D 6319-00 | Meets ASTM D 6319-00 |
| Freedom from holes | Meets ASTM D 6319-00 | |
| Meets ASTM D 5151-99 | Meets ASTM D 6319-00 | |
| Meets ASTM D 5151-99 | ||
| Powder-Free | Meets ASTM D 6319-00 | |
| Not more than 2 mg residue by mass per glove | Meets ASTM D 6319-00 | |
| Not more than 2 mg residue by mass per glove | ||
| Biocompatability (Primary Skin Irritation) | Passes | Passes |
| Biocompatability (Guinea Pig Sensitization) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test within ASTM D 6319-00 or ASTM D 5151-99. These are standardized tests, and the sample sizes are dictated by the respective ASTM standards themselves. The data provenance is not specified beyond being generated by Ansell Healthcare Products Inc., implicitly in the USA. The data would be considered prospective as it's generated specifically for the clearance of this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For these types of medical devices (gloves), the "ground truth" is typically established by physical and chemical testing against recognized industry standards (ASTM standards), rather than by expert consensus on observational data. The standards themselves define the acceptable parameters.
4. Adjudication Method for the Test Set
This information is not applicable in the context of these physical and chemical tests. The "ground truth" is determined objectively by the test results themselves against the pre-defined criteria in the ASTM standards. There is no need for human adjudication of test results in the way it might be applied to image interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for medical examination gloves which are evaluated based on their physical properties, freedom from holes, and biocompatibility, not on interpretive clinical judgments by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study was not done. This device is a physical product (medical glove), not an algorithm or AI system. Therefore, the concept of "algorithm only" performance is not applicable.
7. The Type of Ground Truth Used
The ground truth used is primarily objective measurements against established industry standards (ASTM D 6319-00 and ASTM D 5151-99), along with biocompatibility test results.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI or machine learning model, 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 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.