(279 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 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a" and FDA Water Leak Test.
The provided document describes the acceptance criteria and performance data for "Polymer Coated Online Chlorinated Powder Free Latex Examination Gloves."
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D3578-01aE2 & FDA) | Reported Device Performance (POLYMER COATED ONLINE CHLORINATED POWDER FREE LATEX EXAM GLOVES) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) (all sizes) | Min 230 | 240 mm minimum |
| 3. Palm width (mm) | ||
| Size XS | - | 110 mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties | ||
| Before Aging: | ||
| Tensile Strength (Mpa) | Min 14.0 | 23.9 |
| Ultimate Elongation (%) | Min 650 | 812 |
| After Aging: | ||
| Tensile Strength (Mpa) | Min 14.0 | 19.3 |
| Ultimate Elongation (%) | Min 500 | 741 |
| 6. Powder Content | Below 2mg / glove (FDA requirement) | Below 2mg / glove |
| 7. Protein Content | Below 50 microgram / gram | Below 50 microgram / gram |
| 8. Biocompatibility Tests | Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) test | Pass Biocompatibility Tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. However, it indicates compliance with ASTM D3578-01aE2 standards and FDA requirements. The data provenance is linked to SPI Gloves Sdn. Bhd. in Malaysia, and the tests were likely conducted by or for this manufacturer. The nature of the tests (physical properties, watertightness, etc.) suggests these are controlled laboratory tests rather than observational studies in a real-world setting. The summary was prepared on February 11, 2005.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the performance of examination gloves is established by objective, standardized tests and measurements as defined by ASTM D3578-01aE2 and FDA requirements, not by expert consensus or interpretation of subjective data. Physical properties, chemical content, and watertightness are quantifiable metrics.
4. Adjudication method for the test set
Not applicable. As described above, the performance is measured against objective standards, not subjective interpretation requiring adjudication.
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 device is a medical glove, not an AI-assisted diagnostic tool or an imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not a software algorithm.
7. The type of ground truth used
The ground truth used for evaluating the device is based on objective, quantitative standards and tests specified by:
- ASTM D3578-01aE2 (Standard Specification for Rubber Examination Gloves)
- FDA 1000 ml watertight test
- FDA minimum powder residual content requirements
- Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)
- Protein content testing (below 50 microgram / gram)
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.