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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 (50 Micrograms or Less)

This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)."

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's functional performance metrics.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.

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

OmniGrace Latex Examination Glove, Powder Free, with Protein Claim

This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder-Free, with Protein Claim."

Based on the provided text, there is no information available regarding the acceptance criteria for a device's performance, nor any study proving the device meets said criteria.

The document is an FDA letter acknowledging receipt and review of the 510(k) submission, and confirming that the device, an examination glove, is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness as these details are not present in the provided text.

Ask a specific question about this device