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A patient examination glove is a disposable device intended for medical purpose that A patient examiner's hands or finger to prevent contamination between patient and examiner.

PRE-POWDERED VINYL EXAM GLOVES

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Therefore, I cannot extract the requested information.

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

Vinyl Examination Gloves, Powdered

This document is a 510(k) premarket notification for Vinyl Examination Gloves, Powdered. It is a clearance letter from the FDA. This type of document, particularly for a Class I device like examination gloves, does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the same way a software device submission would.

Medical gloves are considered a low-risk device and their substantial equivalence is primarily based on performance standards and material specifications, rather than complex clinical studies or AI algorithm performance.

Therefore, I cannot provide the requested information because it is not present in the provided document and is generally not applicable to the FDA clearance process for a device of this type.

Here’s why the requested information isn't available for this document:

• Acceptance Criteria & Device Performance: For gloves, the acceptance criteria are typically related to physical properties (tensile strength, elongation, freedom from holes) and chemical safety (biocompatibility). The document mentions the device but does not provide a table of these performance metrics.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are concepts primarily relevant to diagnostic algorithms, AI, or higher-risk devices requiring clinical trials, not basic medical devices like examination gloves. The document confirms substantial equivalence to a predicate device, which means direct comparative testing might have been done for certain physical properties, but not in the format of a "study" with AI or human readers.
• Ground Truth: For gloves, the "ground truth" would be objective measurements of their physical properties and sterility/biocompatibility, not an expert consensus on a diagnosis.
• Training Set: There is no "training set" for a physical device like a glove. This concept applies to machine learning algorithms.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a low-risk medical device (vinyl examination gloves). The detailed study information requested is not part of this type of submission for this particular device.

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