(35 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.
The provided document describes the performance data for "Cashmere Powder Free Latex Examination Gloves" based on ASTM D3578-01 and FDA 1000 ml watertight test.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01) | Reported Device Performance (CASHMERE POWDER FREE LATEX EXAM GLOVES) |
|---|---|---|
| Watertight (1000 ml) | AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) | Min 230 (for all sizes S, M, L) | 240 mm minimum for all sizes |
| Palm width (mm) - Size S | 80 +/- 10 | 82 - 88 |
| Palm width (mm) - Size M | 95 +/- 10 | 92 - 98 |
| Palm width (mm) - Size L | 111 +/- 10 | 102 - 108 |
| Thickness (mm) (Single Layer) - Finger | Min 0.08 | 0.10 minimum |
| Thickness (mm) (Single Layer) - Palm | Min 0.08 | 0.10 minimum |
| Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) | Min 14 | 18.7* |
| Ultimate Elongation (%) | Min 650 | 956* |
| Physical Properties - After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 18.3* |
| Ultimate Elongation (%) | Min 500 | 938* |
| Powder Content | (Implied FDA Requirement: Below 2 mg/glove) | Below 2 mg / glove |
| Protein Content | (Implied FDA Requirement: Below 50 ug/gram) | Below 50 microgram / gram |
* The document states these are "The average result taken from Attachment B2," which is not included in the provided text.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each test. However, it mentions "AQL=4.0%" for the watertight test, which refers to Acceptable Quality Level, a sampling standard. The data provenance is Malaysia and the study appears to be a prospective testing of manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device performance test based on established ASTM standards, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against predefined 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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device in the sense that its performance is measured directly against physical and chemical standards, without human interaction with an algorithm.
7. The type of ground truth used
The ground truth is established by the specified ASTM D3578-01 Standard and FDA requirements for watertightness, powder content, and protein content. These are objective, quantitative standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The "training" for the device would be the manufacturing process itself, and the goal is to consistently produce gloves that meet the specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm. For the manufacturing process, the "ground truth" for the processes (making the gloves) is the ability to consistently achieve the stated performance criteria for the final product.
§ 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.