(169 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.
Latex Exam Glove, Powder Free with Protein and Hypoallergenic Labeling. 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.
The provided document is a 510(k) summary for a Latex Exam Glove, not a complex AI device; therefore, many of the requested categories (like MRMC study, training set, AI vs. human performance) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to established ASTM standards and biological testing.
Here's the information derived from the provided text, structured to best fit your request:
Acceptance Criteria and Device Performance for Latex Exam Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance (Means and/or Results) |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5712 (Protein Content, mg/g against BSA): | |
| Internal Surface | 11 +/- 4 |
| External Surface | 12 +/- 4 |
| FDA Water Leak Test | AQL 4.0 |
| Primary Skin Irritation Test | Met or exceeded |
| Dermal Sensitization Study | Met or exceeded |
| Biocompatibility (Repeated Insult Patch) | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For the Biocompatibility (Repeated Insult Patch) test, 200 subjects were used.
- For other tests (ASTM D 3578-95, ASTM D 5712, FDA Water Leak Test, Primary Skin Irritation Test, Dermal Sensitization Study), specific sample sizes are not explicitly stated in the provided text, but these are typically standardized for such tests.
- Data Provenance: The document does not specify the country of origin of the data. The tests are reported as being conducted for a company registered in Malaysia (Evergrade Healthcare Products Sdn Bhd) based on the address provided in the FDA letter. The study type is prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable for a medical device like a latex exam glove. The "ground truth" for these types of devices is established through adherence to recognized international and national standards (ASTM) and accepted biological testing protocols, not through expert consensus on qualitative assessments.
4. Adjudication Method for the Test Set
Not applicable. Testing involves objective measurements and adherence to pass/fail criteria outlined in the standards, rather than expert 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?
Not applicable. This is a medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device involves:
- Standards Compliance: Adherence to established performance specifications outlined in ASTM D 3578-95 and ASTM D 5712.
- Biological Endpoints: Objective results from biocompatibility testing (primary skin irritation, dermal sensitization, repeated insult patch test) measuring the biological response to the device.
- Physical Properties: Measurable physical properties like water leak integrity (FDA Water Leak Test AQL 4.0) and protein content.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.