(35 days)
A powder-free 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.
Non sterile, Powder free Nitrile Examination Glove, Blue.
The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.
The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.
Here's an analysis of the provided information, addressing the applicable categories:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS (Acceptance Criteria) | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions: overall length; width, palm and finger thickness | ASTM D 6319-10 | Meets |
| Tensile strength: before and after aging | ASTM D 6319-10 | Meets |
| Ultimate elongation: before and after aging | ASTM D 6319-10 | Meets |
| Freedom from holes: pinholes AQL 2.5 | ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6319-10 | Meets |
| Biocompatability (Primary Skin Irritation in Rabbits) | ASTM D 6319-10 (Implicit, as it's a standard for examination gloves) | Passes |
| Biocompatability (Guinea Pig Sensitization) | ASTM D 6319-10 (Implicit, as it's a standard for examination gloves) | Passes |
| Dimensions: overall length; width, palm and finger thickness | ASTM D 6319-10 | Meets |
Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
- Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For this type of device (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.
4. Adjudication method for the test set
- Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical product and does not involve algorithms or AI.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.