(297 days)
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.
The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.
This document describes the premarket notification for the UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961). The study aims to demonstrate that this device is substantially equivalent to a legally marketed predicate device (K010879).
Here's the information broken down by your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the requirements of ASTM D3578-05(2015) and specific values for various properties. The reported device performance is presented alongside the predicate device's performance for comparison.
| Metric | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (UniTex K161961) |
|---|---|---|
| Biocompatibility | ISO 10993-10 - Primary Irritation Test: Non-irritating | Non-irritating (Under the conditions of the study) |
| ISO 10993-10 - Dermal Sensitization Assay: Non-sensitizer | Non-sensitizer (Under the conditions of the study) | |
| Tensile Strength (MPa) | Before Aging: min 18.0 (Subject agrees, Predicate min 21.0) | Before Aging: min 18.0 |
| After Aging: min 14.0 (Subject agrees, Predicate min 16.0) | After Aging: min 14.0 | |
| Elongation (%) | Before Aging: min 650 (Predicate min 700) | Before Aging: min 650 |
| After Aging: min 500 | After Aging: min 500 | |
| Palm Width (Medium size) | 95mm +/- 10 | 95mm +/- 10 |
| Length | 240mm min | 240mm min |
| Thickness (Palm and finger) | Min .08mm Palm and finger (Predicate min .15mm Palm and min .17mm finger) | Min .08mm Palm and finger |
| Waterleak (AQL) | 1.5 (ASTM D5151) | 1.5 |
| Protein Claim | 50 Micrograms or less of total water soluble protein per dm2 (ASTM D5712) | 50 Micrograms or less of total water soluble protein per dm2 |
| Powder Content | Max 2.0mg/glove (ASTM D6124) | Max 2.0mg/glove (Avg .06mg/glove) |
| AQL for Pinholes | 1.5 | 1.5 |
| Quality Assurance | In compliance with ASTM D3578-05, ISO 2859-1:1999, ISO 9001:2008, ISO 13485:2003, EN ISO 13485:2012 | In compliance with ASTM D3578-05, ISO 2859-1:1999, manufactured under ISO 9001:2008, ISO 13485:2003 and EN ISO 13485:2012 |
| Water Tight Test 1000ml (AQL) | 1.5 (G-1 inspection level) | Meets (before and after aging) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test performed to establish device performance. However, for inspection parameters like "Dimensions", "Physical Properties", "Water Tight Test", and "Visual Defects", AQL (Acceptance Quality Limit) levels and inspection levels (e.g., S-2, G-1) are specified. These AQLs determine the sample size and acceptance criteria for lot release, which implies that a sampling plan was followed according to the referenced standards (e.g., ISO 2859-1:1999).
The data provenance is from prospective testing conducted by UG Global Resources Sdn Bhd to demonstrate compliance with the relevant standards for their device. The manufacturing location and potentially the testing facilities are in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is for a medical glove, not an AI/CAD system. Therefore, the concept of "ground truth" as established by medical experts for diagnostic purposes (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the performance of the glove is established by following standardized ASTM and ISO testing protocols, which are objective and quantitative measurements of physical and chemical properties.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The tests are objective and based on established industry standards.
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. This is not an AI/CAD device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/CAD device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance consists of:
- Adherence to ASTM and ISO standards: The device is tested against established specifications outlined in standards like ASTM D3578-05(2015), ASTM D5151, ASTM D5712, ASTM D6124, and ISO 10993-10.
- Quantitative measurements: Physical properties (tensile strength, elongation, dimensions, powder content) and chemical properties (water soluble protein) are measured directly.
- Biocompatibility testing: Standardized in-vivo tests (Primary Irritation Test, Dermal Sensitization Assay) are conducted to determine irritation and sensitization potential.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/CAD device that requires a training set. The performance is assessed through physical and chemical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/CAD 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.