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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.

POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAI

The provided document is a 510(k) premarket notification letter from the FDA to U.O.P. Rubber Products Sdn Bhd regarding their "Powder Free Latex Examination Gloves with Water Extractable Protein Labeling Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain information about:

1. Specific acceptance criteria or reported device performance metrics in a table.
2. Details of any study (e.g., sample sizes, data provenance, expert qualifications, adjudication methods) that would establish the device meets performance criteria for AI/ML.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Standalone algorithm performance studies.
5. Type of ground truth used in such studies.
6. Training set sample size or how its ground truth was established.

This type of FDA letter focuses on the regulatory clearance process for a relatively standard medical device (examination gloves) based on substantial equivalence, rather than a detailed performance study for an AI/ML-driven device. The "Indication For Use" attachment clarifies the intended use of the gloves but does not delve into performance metrics or study designs for AI.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present in the document.

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