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510(k) Data Aggregation
(78 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 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00aE3) | Reported Device Performance (Powder Free Nitrile Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | Depends on size: | Depends on size: |
| Size XS | - | <80 mm |
| Size S | 80 +/- 10 | 85 +/- 3 mm |
| Size M | 95 +/- 10 | 95 +/- 3 mm |
| Size L | 111 +/- 10 | 105 +/- 3 mm |
| Size XL | - | 111 +/- 3 mm |
| Size XXL | - | 120 +/- 3mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | 0.08 minimum |
| Palm | Min 0.05 | 0.08 minimum |
| 5. Physical Properties | ||
| Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 21.8 |
| Ultimate Elongation (%) | Min 500 | 620 |
| After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 25.7 |
| Ultimate Elongation (%) | Min 400 | 584 |
| 6. Powder Content | (Not explicitly specified in table as min/max) | Below 2mg / glove |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It refers to "Attachment C" for the average numbers of physical properties but this attachment is not provided.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. It summarises performance data based on ASTM D6319-00a53 and FDA 1000 ml watertight test, implying a laboratory-based testing environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are standardized material property tests (ASTM D6319-00aE3 and FDA 1000 ml watertight test), which typically involve laboratory technicians or engineers, not "experts" in the medical sense for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are standardized physical and performance tests, not subjective assessments 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
This information is not applicable as this device is a medical glove, not an AI-assisted diagnostic or imaging system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as this device is a medical glove, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by standardized laboratory testing protocols and specifications outlined in ASTM D6319-00aE3 and the FDA 1000 ml watertight test. This is essentially objective physical and performance measurements against predefined benchmarks.
8. The Sample Size for the Training Set
This information is not applicable as this device is a physical product (medical glove) and does not involve machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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