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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim

The provided document is an FDA 510(k) premarket notification letter for a medical device: "Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices and allows it to be marketed.

However, the document does not contain any information regarding the acceptance criteria, device performance, or any studies that prove the device meets specific performance criteria. The FDA letter itself states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements and statutes and regulations administered by other Federal agencies." It primarily focuses on the regulatory clearance process based on substantial equivalence to existing devices, not on a detailed analysis of performance studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter, not a technical report detailing performance studies.

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