(49 days)
The 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.
Powder free, examination gloves made of latex and colored blue. The gloves are provided in sizes small, medium, large and extra large.
The provided document describes the acceptance criteria and study results for the "Textured, Blue, Latex, Powder Free Examination Gloves with Protein Labeling Claim (50µg/dm2 Or Less of Water Soluble Protein)" in the context of an Abbreviated 510(k) Premarket Notification.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM D6124-06 | Meets (values below 2mg of residual powder) |
| Protein Level | ASTM D5712-10 | Meets (values below 50 mcg/g of protein) |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010 (rabbits) | Gloves are non-irritating |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010 (guinea pig) | Gloves do not display any potential for sensitization |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each test listed (e.g., number of gloves tested for dimensions, pinholes, etc.). It only states that the device "Meets" the respective ASTM and ISO standards. These standards would inherently define the required sample sizes for testing, but the document does not explicitly report them.
Data provenance is not explicitly mentioned (e.g., retrospective or prospective, country of origin). However, given these are non-clinical (laboratory/material) tests conducted against established international standards (ASTM, ISO), they are typically conducted in a controlled testing environment, likely in the manufacturer's facility or a certified testing laboratory.
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 this type of device and study. The "ground truth" for examination gloves is established by whether they meet objective, quantifiable physical and chemical standards (ASTM, ISO, and 21 CFR). There are no human "experts" or clinical interpretation involved in establishing the performance criteria for these tests. The tests are designed to objectively measure properties like dimensions, strength, and chemical content.
4. Adjudication method for the test set:
This information is not applicable. Since the tests are objective measurements against defined standards, there is no need for an adjudication method. The results either meet the standard or they do not.
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. This device is a medical glove, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used:
The ground truth used is based on established objective laboratory standards (ASTM and ISO standards) and regulatory requirements (21 CFR 800.20). These standards define specific thresholds and methodologies for evaluating the physical, chemical, and biocompatibility properties of examination gloves.
8. The sample size for the training set:
This information is not applicable as this is not a machine learning or AI-based device that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of 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.