(483 days)
A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
The device is described as a Class I powder-free patient examination glove, made from guayule natural rubber, which meets all of the requirements of ASTM standard D3578-05. A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Physical Properties | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Freedom from Holes | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Powder-free Residue | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| Protein Content | Meets ASTM D 3578-05 | Meets ASTM D 3578-05 |
| No Hevea Antigenic Protein | Per method in ASTM D 6499-03 | Meets method in ASTM D 6499-03 (stated as "Gloves do not contain Hevea antigenic protein") |
| Primary Skin Irritation | Passed testing per 16 CFR Part 1500.41, Method of Testing Primary Irritant Substances AND ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity". | Passed testing per 16 CFR Part 1500.41, Method of Testing Primary Irritant Substances AND ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity". |
| Repeated Patch Dermal Sensitization | Passed testing per ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity", modified to include longer induction exposure period for solid test articles. | Passed testing per ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity", modified to include longer induction exposure period for solid test articles. |
| Latex Category | Meets requirements for Category 4 Latex defined by ASTM D 1076-06 | Meets requirements for Category 4 Latex defined by ASTM D 1076-06 |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for the test set regarding the enumerated performance characteristics. The studies are described as meeting specific ASTM and ISO standards, which inherently include sample size requirements within those standards, but these details are not provided in this summary.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given the context of a 510(k) submission to the US FDA, it is implied that the testing was conducted according to international (ASTM, ISO) or US federal standards (16 CFR).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the device described. The device is a patient examination glove, and its performance is evaluated against engineering, materials, and biocompatibility standards, not through clinical interpretation or expert consensus in the typical sense of a diagnostic device. Ground truth is established through adherence to physical and chemical testing methodologies specified in the standards.
4. Adjudication method for the test set
This information is not applicable to the device. Performance against the specified standards (e.g., ASTM D 3578-05 for physical properties, ASTM D 6499-03 for protein content, ISO 10993-10:2002 for biocompatibility) is determined by direct measurement and observation according to the methods outlined in those standards, not through adjudication by experts.
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
This information is not applicable. The device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical glove. There is no algorithm or AI component involved.
7. The type of ground truth used
The ground truth for this device is based on standardized physical, chemical, and biological testing methods. These methods are defined in established and recognized standards such as:
- ASTM D 3578-05 (for dimensions, physical properties, freedom from holes, powder-free residue, protein content)
- ASTM D 6499-03 (for Hevea antigenic protein content)
- 16 CFR Part 1500.41 (for primary skin irritation)
- ISO 10993-10:2002 (for skin irritation and delayed-type hypersensitivity)
- ASTM D 1076-06 (for latex category)
8. The sample size for the training set
This information is not applicable. As the device is a medical glove and not a machine learning model, there is no "training set" in the context of AI. The product undergoes manufacturing quality control and batch testing to ensure consistency with the established performance criteria.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this device.
§ 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.