(70 days)
The Nugard Black Powder Free Latex Examination Glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
The provided text is an FDA 510(k) clearance letter for a medical device: "Nugard Black Powder Free Latex Examination Glove, Polymer Coated."
This document is a regulatory clearance and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way one would describe for a diagnostic or algorithmic device. It's a clearance for a Class I medical device (patient examination glove), which typically relies on established performance standards for similar devices rather than novel clinical studies to demonstrate analytical or clinical performance.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the information provided in this regulatory document.
However, I can extract the relevant information regarding the device's characteristics and the implied "acceptance criteria" for this type of device, which typically involves compliance with recognized standards.
Here's a breakdown based on the provided text, highlighting what is present and what is not:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material: Natural Rubber Latex | Device is made of natural rubber latex. |
| Coating: Polymer Coated | Device is Polymer Coated. |
| Powder: Powder Free | Device is Powder Free. |
| Protein Content (Water Extractable): Contains 50 Micrograms or Less | Contains 50 Micrograms or less of water extractable protein. |
| Intended Use: Worn on examiner's hand to prevent contamination between patient and examiner. | (This is the stated Indication for Use, implying the device performs this function). |
| Sterility: Not specified (implies non-sterile for examination gloves unless otherwise stated, which is typical for examination gloves) | (Not specified in this document, but implied by "examination glove"). |
| Disposable: Disposable device. | Device is a disposable device. |
| Regulatory Class: Class I, Patient Examination Glove | Device is a Class I Patient Examination Glove. |
| Regulation Number: 21 CFR 880.6250 | Device falls under 21 CFR 880.6250. |
| Product Code: LYY | Device has Product Code LYY. |
Explanation: For Class I devices like examination gloves, the "acceptance criteria" are generally derived from recognized consensus standards (e.g., ASTM standards for medical gloves) that address physical properties, barrier integrity (e.g., freedom from holes), biocompatibility, and protein content for latex gloves. The document confirms that the device meets the description of these characteristics, which serves as the "reported device performance" in this context. The mention of "50 micrograms or less of water extractable protein" is a specific performance claim related to latex allergenicity, common for "low protein" latex gloves.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided in this document. The FDA 510(k) clearance letter does not detail the specific testing methodologies (like sample size or data provenance) used by the manufacturer to demonstrate compliance with performance standards for physical characteristics, barrier integrity, or protein content. This information would be within the manufacturer's 510(k) submission, not typically in the clearance letter itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided in this document. Ground truth establishment by experts is typically for diagnostic devices where subjective interpretation (e.g., imaging, pathology slides) is involved. For a physical device like a glove, "ground truth" relates to objective measurements against ASTM or ISO standards (e.g., tensile strength, dimensions, freedom from holes, protein assay results). These tests do not typically involve human expert consensus for interpreting results but rather adherence to validated laboratory methods.
4. Adjudication method for the test set
- Not Applicable / Not Provided in this document. Adjudication methods (like 2+1, 3+1) are relevant to studies where human readers are making subjective assessments that need to be resolved. This is not pertinent to the evaluation of a physical product like a glove, which is assessed through objective, standardized laboratory 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
- Not Applicable. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess the impact of AI on human reader performance. This device is a physical medical glove and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical product, not an algorithm. Standalone performance refers to the performance of an AI algorithm independent of human interaction.
7. The type of ground truth used
- Implied Ground Truth: For physical characteristics (like dimensions, tensile strength) and chemical properties (like protein content, chemical integrity), the ground truth is established through objective laboratory measurements and validated assays performed according to recognized consensus standards (e.g., ASTM D3577 for latex examination gloves, or specific methods for protein content). The FDA's substantial equivalence determination implies these tests were conducted and met the relevant specifications for predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided in this document. Training sets are used in machine learning for AI algorithms. This device is a physical product.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided in this document. As with the training set itself, "ground truth" establishment for a training set is relevant to AI/ML development, which is not applicable here.
§ 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.