(76 days)
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Chlorinated Powder Free Latex Examination Gloves
This document is an FDA 510(k) clearance letter for "Chlorinated Powder Free Latex Examination Gloves." This type of document is generally about regulatory approval of a medical device and does not typically contain detailed acceptance criteria or study results in the manner requested. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, subject to general controls provisions.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided:
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A table of acceptance criteria and the reported device performance: This document does not contain specific acceptance criteria or detailed performance data for the "Chlorinated Powder Free Latex Examination Gloves." The FDA clearance is based on substantial equivalence, implying the device meets the standards of its predicate without necessarily requiring a report of novel performance data.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or available for this type of device clearance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or available for this type of device clearance.
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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 device is an examination glove, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this type of device (examination glove). The "ground truth" for a medical glove typically relates to its material properties, barrier function, and sterility, which are assessed through standardized tests rather than clinical outcomes or expert consensus on interpretations.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, this document is a regulatory approval letter based on substantial equivalence and does not contain the detailed technical or clinical study data requested.
§ 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.