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510(k) Data Aggregation
(84 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand on finger to prevent contamination between patient and examiner.
Pre-Powdered Latex Examination Gloves With Protein Labeling Claim (180 us
The provided document is an FDA 510(k) clearance letter for a medical device: "Pre-Powdered Latex Examination Gloves with Protein Labeling Claim, Contains 180 Micrograms or Less of Total Water Extractable Protein Per Gram".
This document describes the regulatory clearance of a physical medical device (gloves), not an AI/ML-driven device. Therefore, the requested information regarding acceptance criteria and studies that prove an AI device meets those criteria (including sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.
The document indicates that the device was found "substantially equivalent" to legally marketed predicate devices, meaning it does not require new clinical studies to prove effectiveness or safety in the same way an AI device would. The core "acceptance criteria" here relate to meeting the specifications of a predicate device and complying with general controls for medical devices (e.g., manufacturing practice, labeling).
In summary, none of the specific AI/ML-related questions can be answered from this document because it pertains to a different type of medical device.
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(240 days)
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(42 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand, or finger to prevent contamination between patient and examine.
Latex Patient Examination Gloves, Powder-Free (with Protein Content Claim (50hicrogram or less) Labelling of Powder-Free)
This document is a 510(k) premarket notification decision letter from the FDA regarding a latex, powder-free examination glove. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document confirms that the device is substantially equivalent to a predicate device marketed before May 28, 1976.
Therefore, I cannot provide the requested information based on the provided text.
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