(37 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 betweeen patient and examiner.
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
This is a 510(k) summary for a non-sterile, powder-free nitrile examination glove. It outlines the device's characteristics, intended use, and a comparison to established standards and a predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Physical Properties | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae3 | Meets ASTM D 6319-00-ae3 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | ≤2 mg/glove (as per standard) | ≤2 mg/glove |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for testing each characteristic. It only states that the performance tests were conducted. The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. The country of origin of the data is not explicitly stated for the testing itself, but the manufacturer is based in Thailand. The study is retrospective in the sense that the testing was conducted prior to the submission for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable to this type of device. The "ground truth" for the performance characteristics of an examination glove is defined by the technical specifications and testing methods described in the referenced ASTM standards (e.g., ASTM D 6319-00-ae3, ASTM D 6124-2001) and biocompatibility test protocols. These standards dictate objective measurements rather than subjective expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. The performance testing of examination gloves involves laboratory measurements against established standards, not a process requiring adjudication among human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tools where human interpretation plays a significant role and can be enhanced by AI assistance. This device is a disposable medical glove, and its performance is assessed through physical and chemical testing, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not a function of an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established industry standards and scientifically recognized test methods. Specifically:
- ASTM D 6319-00-ae3: Specifies ground truth for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from pinholes for nitrile examination gloves. These are objective, measurable criteria.
- ASTM D 6124-2001: Specifies the ground truth for powder-free residue, which is a quantitative measurement.
- Biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization): These involve standardized animal testing protocols where "passes" indicates the absence of a defined level of adverse reaction, serving as the ground truth for biological safety.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for manufacturing such a device would involve process control and quality assurance, not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of this 510(k) submission for a physical medical device like an examination glove.
§ 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.