(20 days)
The Green Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
The provided document describes a 510(k) submission for a medical examination glove, which is a low-risk device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than extensive clinical studies with complex acceptance criteria and ground truth establishment typically seen for higher-risk devices or AI/ML-driven diagnostics.
Therefore, many of the requested categories are not applicable or do not have direct equivalents in this type of submission.
Here's an analysis based on the provided text, indicating where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Performance Standards | ASTM standards | ASTM standards (meets or exceeds) |
| Watertightness | ASTM standards | ASTM standards (meets or exceeds) |
| Safety (Non-clinical tests) | ||
| Rabbit Irritation | Passes (Implied by predicate performance) | Passes |
| Guinea Pig Sensitization | Passes (Implied by predicate performance) | Passes |
| Modified Draze Test | Passes (Implied by predicate performance, though not performed on proposed device, similarity is key) | N/A (Similarity to predicate device is the basis for not repeating this specific test) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as this is a non-clinical, performance-based comparison to a predicate device, not a human reader study or clinical trial with a defined "test set" in the context of diagnostic accuracy.
- Data Provenance: The data refers to "Non-clinical tests (Human Study)" (referring to aspects like rabbit irritation and guinea pig sensitization, which use animal models, not human subjects for testing the glove's barrier properties or direct clinical performance). The provenance is best manufacturing company and not a country of origin. This is retrospective in the sense that the test results for the predicate are already established, and the proposed device is being evaluated against those established results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve human expert interpretation of data to establish a "ground truth" for diagnostic purposes. The ground truth for glove performance is established by standardized ASTM tests and animal safety models.
4. Adjudication method for the test set
- Not Applicable. There is no adjudication method in the context of expert review for diagnostic agreement as this is not a diagnostic device or a clinical study involving human judgment on cases.
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 examination glove, not an AI-assisted diagnostic device. Therefore, no MRMC study with human readers and AI assistance was performed.
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 or software. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used
- Standardized Performance Metrics: The "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for watertightness and "Performance Standards," as well as results from standardized biocompatibility tests (Rabbit Irritation, Guinea Pig Sensitization, Modified Draze Test). These are objective, laboratory-based measurements rather than expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set. The "training" for this device comes from the established manufacturing processes and material science, and its substantial equivalence is based on direct comparison to an already approved device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set involved, the concept of establishing ground truth for it does not apply.
§ 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.