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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Pink Color

This document is an FDA 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Exam Glove, Pink Color." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The request asks for specific information about acceptance criteria and a study proving a device meets those criteria. However, this document is a regulatory approval letter for a medical glove, which is a low-risk device. It does not contain the detailed technical performance study information typically found in submissions for more complex diagnostic AI/ML devices.

Therefore, I cannot provide the requested information from this document, as it does not describe a study involving "acceptance criteria" for an AI/ML device, nor does it provide performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The information I can extract directly from the document is:

• Device Name: Disposable Powder Free Vinyl Exam Glove, Pink Color
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LYZ
• Indications for Use: "A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."

This type of device (medical gloves) is subject to general controls and substantial equivalence determination, not the kind of detailed performance study described in the prompt.

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