Search Results
Found 1 results
510(k) Data Aggregation
(26 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.
POWDERED LATEX EXAM GLOVES, WITH PROTEIN LABELING (200 ug/g or less)
The provided document describes a 510(k) submission for powdered latex exam gloves. It does not describe an AI/ML powered device, therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's the information extracted from the provided text:
Acceptance Criteria and Reported Device Performance
Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
---|---|---|
Physical Properties / Standards | ASTM D 5712-99 (Standard Specification for gloves for medical application) | Met or exceeded |
ASTM D 3578-01 (Standard Specification for Rubber Examination Gloves) | Met or exceeded | |
ASTM D 6124-99 (Standard Test Method for Residual Powder on Medical Gloves) | Met or exceeded | |
ASTM D 5151-99 (Standard Test Method for Detection of Holes in Medical Gloves) | Met or exceeded | |
ISO 2859 (Sampling Procedures for Inspection by Attributes – not a direct test, but a standard for sampling) | Met or exceeded | |
Biocompatibility | Dermal Sensitization | Met or exceeded |
Primary Skin Irritation | Met or exceeded | |
Protein Labeling | 200 ug/g or less of total water extractable protein per gram (This is stated in the device name and regulation number description, implying it's a key characteristic that needs to be met) | Implicitly met, as the device is formally described with this labeling and was deemed substantially equivalent, suggesting this characteristic was verified against predicate devices. |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size for each test conducted (e.g., number of gloves tested for each ASTM standard or biocompatibility).
- Data Provenance: The tests were performed by the manufacturer, Hycare International Co., Ltd. (Thailand), implying in-house or contracted testing. The country of origin of the data is not specified beyond the manufacturer's location in Thailand. The study is prospective in nature, as new testing was conducted on the device to demonstrate conformance to standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a medical device (exam glove) submission, not an AI/ML-powered diagnostic or screening device. The "ground truth" here refers to the physical and biological performance of the glove as measured against established industry standards. These standards (ASTM, ISO) define objective measurement methods and acceptance limits, rather than relying on expert consensus for "ground truth" in the way an AI diagnostic system would.
-
Adjudication method for the test set:
- N/A. As above, this is a physical medical device. Performance is determined by objective measurements against predefined standards (e.g., tensile strength, barrier integrity, protein content, skin reaction) rather than a panel of experts adjudicating results.
-
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:
- N/A. This is not an AI/ML-powered device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML-powered device.
-
The type of ground truth used:
- The "ground truth" for this device's performance is based on objective measurement against established industrial and medical standards (ASTM, ISO, and biocompatibility tests). These standards define the acceptable range for physical properties and biological responses, as detailed in the "Acceptance Criteria" table.
-
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set in the typical machine learning sense. The manufacturing process is validated through quality control and adherence to standards, but not a "training set."
-
How the ground truth for the training set was established:
- N/A. Not applicable for this type of device.
Ask a specific question about this device
Page 1 of 1