(35 days)
A 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.
The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves.
The provided document is a 510(k) summary for a Nitrile Examination Glove. It details the safety and effectiveness of the device as required for FDA clearance. The information you're asking for, acceptance criteria and study details related to a device performance study that proves the device meets the criteria, is present in the document.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a table with explicit "acceptance criteria" alongside "reported device performance" in a structured side-by-side manner. However, it lists the standards and tests performed, implying that the acceptance criteria are embedded within these standards, and the reported performance is that the device "met and/or exceeded the requirements."
Here's an interpretation based on the provided text:
| Acceptance Criteria (Implied by Standard/Test) | Reported Device Performance |
|---|---|
| Requirements of ASTM D3578-95 | Met and/or exceeded |
| Primary Skin Irritation Study | Met and/or exceeded |
| Dermal Sensitization Study | Met and/or exceeded |
| FDA Water Leak (AQL 1.5) before aging | Met and/or exceeded |
| FDA Water Leak (AQL 1.5) after aging | Met and/or exceeded |
Note: The document explicitly states: "The device has met and/or exceeded the requirements of the following standards and laboratory tests." This indicates positive performance against the implicit acceptance criteria of these standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each of the listed tests (e.g., for ASTM D3578-95, Primary Skin Irritation Study, Dermal Sensitization Study, or FDA Water Leak tests). These would typically be defined by the specific ASTM standards or FDA guidelines referenced.
- Data Provenance: The document does not specify the country of origin of the data. It mentions that "All tests were performed in a certified testing laboratory," but does not name the laboratory's location or whether the data was retrospective or prospective. It is highly likely to be prospective testing specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to this type of device and study. The "device" in question is a nitrile examination glove. The performance evaluation is based on objective physical, chemical, and biological tests (e.g., ASTM standards, skin irritation tests, water leak tests), not on human expert interpretation of data or images where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret medical images or data and their performance needs to be assessed against a consensus ground truth. The tests for a medical glove are objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This section is not applicable. An MRMC study is relevant for diagnostic medical devices where multiple human readers assess cases with and without AI assistance. This document describes the performance of a physical medical device (examination glove) based on standardized laboratory tests, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This section is not applicable. This question refers to the performance of an AI algorithm in isolation. The document describes a physical medical device and its performance is evaluated through physical, chemical, and biological tests, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the nitrile examination glove is established by:
- Standards: The requirements defined in ASTM D3578-95.
- Laboratory Test Outcomes: Objective results from "Primary Skin Irritation Study," "Dermal Sensitization Study," and "FDA Water Leak" tests, which have defined pass/fail criteria. These are empirical, measurable standards, not expert consensus or pathology in the context of diagnostic devices.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (nitrile examination glove), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.