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510(k) Data Aggregation
K Number
K052635Manufacturer
Date Cleared
2005-12-13
(78 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
A medical glove is a disposable device which is worn on the hand of healthcare personnel to prevent contamination between patient and examiner.
Device Description
Powdered Synthetic Vinyl Patient Examination Gloves, Yellow
AI/ML Overview
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Powdered Synthetic Vinyl Patient Examination Gloves, Yellow." It primarily discusses the substantial equivalence determination for this medical glove and regulatory compliance.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study details
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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