(99 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.
Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)
This is a 510(k) premarket notification for examination gloves. The document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than providing a detailed study report with acceptance criteria and performance data for a novel device or AI algorithm.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) is not applicable or not provided in the given text because this document is describing the regulatory approval of a medical device (examination gloves) based on substantial equivalence, not a study performing to acceptance criteria of a novel device.
Here's what can be extracted based on the nature of the device (examination gloves) and the provided text:
- Device Name: Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less); Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less); Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: I
- Product Code: LYY
- Indication For Use: 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.
Regarding the protein content labeling claim (50 micrograms or less), this likely refers to a performance characteristic that would have acceptance criteria for the device if a new device were being tested for this claim. However, the provided text does not describe an independent study to prove this claim, but rather the regulatory approval process which would typically rely on manufacturer data and comparison to predicate devices that also meet such claims.
Summary based on the input:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document is a regulatory approval letter based on substantial equivalence, not a detailed study report. The mention of "Protein Content Labeling Claim (50 Micrograms or less)" implies a performance target, but no specific acceptance criteria or reported performance data from a study is presented in this document.
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Sample sized used for the test set and the data provenance:
- Not applicable/Not provided. This document does not describe a performance study for the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment is not relevant for the regulatory approval of examination gloves based on substantial equivalence.
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Adjudication method for the test set:
- Not applicable/Not provided.
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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. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used:
- Not applicable/Not provided.
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The sample size for the training set:
- Not applicable/Not provided.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.