(38 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
DermaClean Sterile (Protein Labeling Claim) examination gloves, meet all of the requirements of ASTM D 3578. DermaClean Sterile (Protein Labeling Claim) examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves. DermaClean Sterile (Protein Labeling Claim) examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Freedom from holes | Meets ASTM D 3578 & ASTM D 5151 | Meets ASTM D 3578 & ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass | Not more than 2 mg residue by mass |
| Protein Label Claim | 50 micrograms or less of total water extractable protein per gram | 50 micrograms or less of total water extractable protein per gram |
| Biocompatibility - Primary Skin Irritation in Rabbits | Passes | Passes |
| Biocompatibility - Guinea Pig Sensitization | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., freedom from holes, physical properties). However, it implies that the tests were conducted according to the respective ASTM standards, which would dictate appropriate sample sizes for each test.
The data provenance is not explicitly stated in terms of country of origin but is implicitly from Ansell Perry Inc. in Massillon, Ohio, USA. The studies are retrospective as they are internal validation tests against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The ground truth for the performance of the gloves is established by the well-defined and objective criteria set forth in the ASTM standards (ASTM D 3578, ASTM D 5151) and the documented residue limits and protein content limits. These are not subject to expert interpretation for ground truth establishment in the same way as, for example, medical image diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable. The performance is assessed against objective, measurable standards as outlined in the ASTM specifications and internal test methods. There is no need for expert adjudication in the traditional sense for these types of physical and chemical tests.
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
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic tools where human interpretation is involved. This device is a medical glove, and its performance is assessed through physical and chemical properties, not by human interpretation that could be augmented by AI.
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 physical product (medical glove), not an algorithm or AI system. Its performance is inherent to the product itself, not to a computational model.
7. The type of ground truth used
The ground truth used for these tests is based on objective, measurable criteria defined by established industry standards (ASTM D 3578, ASTM D 5151) and specific numerical thresholds (e.g., 2 mg residue, 50 micrograms protein). These standards provide the definitive "ground truth" for what constitutes acceptable performance for a medical examination glove.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, and its performance is determined by its design, materials, and manufacturing process, not trained using a dataset in the way an AI model is. There is no concept of a "training set" for physical product testing in this context.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this product. The ground truth for acceptable performance is established by the aforementioned ASTM standards and specific limits.
§ 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.