(31 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The provided text is a 510(k) summary for a medical device, specifically non-sterile powder-free polymer-coated latex examination gloves. It details the device's technical specifications and how its performance was evaluated against established standards for regulatory clearance. It does not describe a study involving an AI-powered device or human readers.
Therefore, many of the requested categories regarding AI, expert involvement, and MRMC studies are not applicable to this document.
Here's the information that can be extracted from the provided text, structured according to your request where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (EVERGREEN POWDER FREE LATEX EXAM. GLOVES) |
|---|---|---|
| Watertight (1000ml) | GII, AQL = 4.0% | Pass GII, AQL = 4.0% |
| Length (mm) - XS, S, M, L, XL | Min 230 for all sizes | 240 mm minimum for all sizes |
| Palm width (mm) - S | 80 ± 10 | 83 - 88 |
| Palm width (mm) - M | 95 ± 10 | 93 - 98 |
| Palm width (mm) - L | 111 ± 10 | 103 - 107 |
| Palm width (mm) - XS, XL | - (Not specified in standard for these sizes) | 73 - 78 (XS), N/A (XL, value not given for XL) |
| Thickness (mm) (Single Layer) - Finger | Min 0.08 | Min 0.10 |
| Thickness (mm) (Single Layer) - Palm | Min 0.08 | Min 0.10 |
| Physical Properties (Before Aging) - Tensile Strength (Mpa) | Min 14 | 23 - 27 |
| Physical Properties (Before Aging) - Ultimate Elongation (%) | Min 700 | 830 - 870 |
| Physical Properties (After Aging) - Tensile Strength (Mpa) | Min 14 | 23 - 26 |
| Physical Properties (After Aging) - Ultimate Elongation (%) | Min 500 | 820 - 850 |
| Powder Content | - (FDA Requirements: below 2 mg/glove by implication from conclusion) | Below 2 mg/glove |
| Protein Content | - (Label claim: ≤ 50 micrograms/gram of glove) | Below 50 microgram/gram |
| Bio-compatibility Test | Pass (implied requirement for medical devices) | Passed 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 (number of gloves) used for each individual test. It states that "Performance data of gloves based on ASTM D3578-95 and FDA 1000ML watertight test" were conducted. ASTM standards typically define sampling plans, which would have been followed, but the specific numbers are not in this summary.
Data Provenance: The testing was conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). The data would be prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with the standards.
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 this device is defined by physical and chemical performance standards (ASTM D3578-95 and FDA requirements), not expert consensus on interpretations of data. The tests are objective measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of results. The tests are based on direct measurement and comparison against predefined thresholds in 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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is defined by established industry standards (ASTM D3578-95) and regulatory requirements (FDA's 1000ML watertight test, powder content, and protein content limits). These are objective, measurable criteria for glove performance.
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.