(50 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.
Chlorinated, Polymer-Coated , Powder-free , Latex Patient Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. This document approves the device for marketing based on its substantial equivalence to legally marketed predicate devices.
The information you are requesting about acceptance criteria and study details (such as sample size, ground truth, expert qualifications, adjudication methods, and MRMC studies) is typically found in the device's 510(k) summary or a more detailed submission document, not in the approval letter itself. The approval letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent, implying that the submitted data met the necessary criteria for equivalence.
Therefore,based on the provided document, I cannot fulfill your request for the following reasons:
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No Acceptance Criteria or Performance Data: The letter does not specify any quantitative acceptance criteria or report device performance metrics (e.g., sensitivity, specificity, accuracy, or physical property measurements like tensile strength, elongation, or barrier integrity for a glove). It states that the device is "substantially equivalent," which means it performs as safely and effectively as a predicate device, but the specific metrics used for that determination are not detailed here.
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No Study Details: The letter does not include information about:
- Sample sizes used for testing.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance (this device is a physical medical glove, not an AI algorithm).
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
In summary, the provided document is an FDA approval letter for a medical glove, not a detailed technical report or study summary. Therefore, it does not contain the information requested about acceptance criteria and study specifics.
To obtain this information, one would typically need to consult the full 510(k) submission document or summary, which may be available through the FDA's public databases.
§ 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.