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A powder-free 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 Nitrile Examination Gloves, Orange Color

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for "Powder-Free Nitrile Examination Gloves, Orange Color" (K141021). This letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new Premarket Approval Application (PMA).

The letter primarily focuses on:

• The trade/device name and regulation information.
• The substantial equivalence determination.
• General controls and regulations applicable to the device.
• Contact information for FDA guidance.
• The "Indications for Use" for the gloves, which defines their intended medical purpose.

There are no details about:

• Specific performance acceptance criteria for the gloves (e.g., tensile strength, puncture resistance, barrier integrity metrics).
• Any study (clinical or non-clinical) that was conducted to demonstrate performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment, experts, or adjudication methods.
• MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI or software device.

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