(149 days)
Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.
Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 10 Standard Specification for Nitrile Examination Gloves for Medical Application¹. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are powder free gloves.
The provided text describes powdered-free nitrile examination gloves and their compliance with ASTM standards, rather than an AI/ML powered device. Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document.
However, I can extract the acceptance criteria and performance as described for the gloves.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM D 6319-10) | Reported Device Performance |
|---|---|
| Physical Properties (Dimensions, Tensile Strength, Elongation) | Meets all current specifications |
| Freedom from holes (AQL for pinholes) | Meets AQL requirements |
| Barrier integrity | Meets requirements |
| Biocompatibility (Primary Skin Irritation) | No irritation observed in rabbits |
| Biocompatibility (Delayed Dermal Contact Sensitization) | No sensitization observed in guinea pigs |
Specific numerical values for tensile strength, elongation, and AQL for pinholes are not explicitly provided in the summary but are stated to meet the ASTM D 6319-10 standard. The document states, "Gloves meet all the current ASTM D 6319-10." and "Non-Clinical laboratory and animal based test data indicate that the powder free product meets all performance and biocompatibility requirements."
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set for all physical and barrier integrity tests. For biocompatibility tests:
- Primary skin irritation: Conducted in rabbits (number of rabbits not specified).
- Delayed dermal contact sensitization: Conducted in guinea pigs (number of guinea pigs not specified).
- Data provenance: The testing was performed in Thailand by W.A. Rubbermate Co., Ltd. The study appears to be non-clinical (laboratory and animal-based).
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 as the device is a medical glove, not an AI/ML device requiring expert ground truth for classification or diagnosis. Performance is based on standardized physical and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and testing.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used
For the glove's performance:
- Physical properties: Measured values (e.g., dimensions, tensile strength, elongation) compared against the specifications in ASTM D 6319-10.
- Freedom from holes: Determined by established inspection methods (e.g., water leak test) and statistical sampling plans (AQL) as defined in ASTM D 6319-10.
- Biocompatibility: Observed biological responses (irritation, sensitization) in animal models compared against established safety criteria.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical glove testing.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML 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.