(197 days)
A powder-free 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. It is for over-the-counter use.
White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.
The provided text describes a 510(k) summary for Nitrile Examination Gloves and does not contain information about a study with acceptance criteria for a device involving AI or expert review. Instead, it details the characteristics and performance of medical gloves against established ASTM standards and biocompatibility tests.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these topics are not present in the document.
However, I can extract the acceptance criteria and reported device performance for the Nitrile Examination Gloves based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (RS WHITE Nitrile Medical Examination Gloves Powder Free) |
|---|---|---|
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pinholes | ASTM D 6319-10 | Meets |
| Powder-Free | ASTM D 6319-10 | Meets |
| Biocompatibility | ||
| Primary Skin | Consumer Product Safety Commission, | Passes |
| Irritation Test | Title 16, Chapter II, Part 1500 | |
| Dermal Sensitization | ISO 10993-10:2010(E) | Passes |
Explanation for Missing Information:
The request implicitly assumes the device is an AI-driven medical device requiring clinical studies with human expert input. The provided text, however, relates to a Class I medical device (Nitrile Examination Gloves) where "acceptance criteria" are based on compliance with established industry standards (ASTM) and biocompatibility tests, rather than clinical efficacy studies in the context of diagnostic or therapeutic AI.
Therefore, the following points cannot be addressed from the given document:
- Sample size used for the test set and the data provenance: Not applicable, as this is a product-testing conformity document, not a clinical study on a dataset.
- 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 defined by the technical specifications in the ASTM standard and the results of laboratory tests.
- Adjudication method (e.g., 2+1, 3+1, none) 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 is defined by the objective physical and chemical properties and performance markers specified in ASTM D 6319-10 and biocompatibility testing protocols.
- The sample size for the training set: Not applicable. Manufacturing processes are typically controlled by quality assurance and quality control testing, not machine learning training sets.
- How the ground truth for the training set was established: Not applicable.
§ 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.