(28 days)
A 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.
Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
Viryl Patient Examination Glove, Power Free, 80LYZ
conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
This document describes the performance of the Vinyl Patient Examination Gloves, Powder Free, manufactured by Everrise Glove Products Co., Ltd.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against ASTM Standard D5250-92 and FDA water leak test requirements.
| Test | Acceptance Criteria (ASTM D5250-92 & FDA) | Reported Device Performance (Applicant Device) |
|---|---|---|
| Length (mm) | ||
| Size S | Min. 230mm | 240±5mm |
| Size M | Min. 230mm | 240±5mm |
| Size L | Min. 230mm | 240±5mm |
| Size XL | Min. 230mm | 240±5mm |
| Width (mm) | ||
| Size S | 85±5mm | 87±3mm |
| Size M | 95±5mm | 97±3mm |
| Size L | 105±5mm | 107±3mm |
| Size XL | 115±5mm | 114±3mm |
| Thickness (mm) | ||
| Finger | Min. 0.05mm | Min. 0.08mm |
| Palm | Min. 0.08mm | Min. 0.11mm |
| Physical Properties (Before Aging) | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| Physical Properties (After Aging) | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | Meet AQL 4.0 (for pin-holes with 1000ml water leak test) | Meets AQL 4.0 with an Inspection Level of S-4 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for the physical property tests (length, width, thickness, tensile strength, ultimate elongation) or the FDA water leak test. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The studies are non-clinical performance studies conducted on the applicant's device. No information on whether they were retrospective or prospective is provided, but standard test methods like ASTM D5250-92 are typically conducted prospectively on a sample set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical product (gloves), and performance is assessed against established engineering and safety standards (ASTM D5250-92 and FDA water leak test), which do not involve expert interpretation or ground truth establishment in the way an AI diagnostic algorithm would.
4. Adjudication method for the test set:
Not applicable. Performance is measured against quantitative standards, not through adjudication of expert opinions.
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 a physical medical device (examination gloves), not an AI-powered diagnostic tool engaging human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used:
The "ground truth" for this device's performance is defined by the objective, measurable criteria specified in ASTM Standard D5250-92 and the FDA 1000ml water leak test. These are engineering and quality control standards.
8. The sample size for the training set:
Not applicable. There is no training set as this is a physical product evaluated against standards, not a machine learning algorithm.
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.