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510(k) Data Aggregation
(152 days)
The Powder free nitrile examination gloves (white, blue and black) 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.
Powder Free Nitrile Examination Gloves (White, Blue and Black)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves (White, Blue and Black)". It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. However, it does not contain any information about:
- Acceptance criteria for device performance studies.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training sets.
This document is a regulatory approval letter, not a study report detailing performance data. Therefore, I cannot generate the requested table and information based on the provided text.
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(86 days)
A Synthetic Vinyl Examination Gloves, powder free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Synthetic Vinyl Examination Gloves, Powder-Free
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification approval letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device that would typically involve such metrics (like an AI/ML powered device).
The information in the document pertains to regulatory approval for a physical medical device (gloves) and confirms its substantial equivalence to previously marketed predicate devices. It discusses general controls, regulations, and contact information, but not the kind of performance study details you are asking for.
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