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Powdered vinyl 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 examiner.

powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.

The provided document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)". This is a Class I medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information details the acceptance criteria and the methods used to prove the device meets these criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder free vinyl 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 examiner.

powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow)":

1. Table of Acceptance Criteria and Reported Device Performance

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This powdered, vinyl 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 examiner (21CFR 880.6250).

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-004.

The provided text is a 510(k) Premarket Notification Summary for Powdered Vinyl Patient Examination Gloves, White (Non-colored). This type of document is about demonstrating substantial equivalence to a predicate device, not necessarily proving novel clinical effectiveness or advanced AI performance. As such, the requested information regarding AI device acceptance criteria, expert adjudication, MRMC studies, and standalone algorithm performance, as well as specific details about training and test sets common for AI/ML device submissions, are not applicable to this traditional medical device submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests conducted to ensure the gloves meet established standards for similar devices.

Here's the relevant information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device

Ask a specific question about this device