(70 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.
Vinyl Powder-Free Examination Gloves with coating are formulated using Vinyl and offered powder-free.
The provided text describes a 510(k) summary for "Esteem Stretchy Synthetic with Neu-Thera" examination gloves, not an AI medical device. Therefore, the specific criteria for AI device studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.
However, I can extract the acceptance criteria and the results of the studies performed for these examination gloves as described in the document.
Acceptance Criteria and Reported Device Performance for Esteem Stretchy Synthetic with Neu-Thera Examination Gloves
| Test | Acceptance Criteria (Implied by "meet or exceed requirements") | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No irritation | Gloves show no irritation. |
| Guinea Pig Maximization | No potential for irritation (sensitization) | Gloves do not display any potential for irritation. |
| Tensile Strength | Meet or exceed requirements per ASTM D5250-00e4 | Gloves meet or exceed requirements per ASTM D5250-00e4. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20 and ASTM D5250-00e4 (for pinholes/leaks) | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D5250-00e4. |
Regarding the AI-specific questions, based on the provided document, the following are not applicable or cannot be determined:
- Sample sized used for the test set and the data provenance: This information is not relevant for a glove performance test.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is based on standardized physical and biological testing methods.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove testing is derived from standardized laboratory procedures, chemical analysis, and in-vivo (animal) as well as in-vitro (physical property) testing, typically against established ASTM and CFR standards.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
§ 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.