(154 days)
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (blue)".
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory requirements and contact information for further inquiries.
The "Indications for Use" section specifies the intended purpose of the glove: "a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
Because the document pertains to a Class I medical device (patient examination glove), the regulatory pathway does not typically involve the kind of detailed performance studies and acceptance criteria that would be required for more complex devices or software as a medical device (SaMD). The substantial equivalence determination is usually based on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness.
Therefore, none of the specific questions regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies can be answered from the provided text.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.