Search Results

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(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided K051935 Premarket Notification [510(k)] Summary pertains to "Powder Free Vinyl Patient Examination Gloves, White (non-colored)". This device is a medical glove, and the acceptance criteria and study detailed are for demonstrating its compliance with relevant standards and safety.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

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(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided is standard for this type of device and does not involve complex AI algorithms or detailed clinical studies in the way you might expect for an AI-powered diagnostic tool. Therefore, many of your requested items, such as expert adjudication, MRMC studies, and detailed training set information, are not applicable in this context.

Here's an analysis based on the provided document:

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

Ask a specific question about this device

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(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

Acceptance Criteria and Device Performance

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

Ask a specific question about this device

This 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(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

Ask a specific question about this device