(214 days)
Non Sterile Powder Free Polyurethane Examination Glove (Blue and Black colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
This document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information regarding acceptance criteria, device performance metrics, or study details (sample size, data provenance, ground truth establishment, MRMC studies, standalone performance, etc.) for a medical device that would typically involve such a study (e.g., an AI-powered diagnostic device or a complex therapeutic device).
The information provided is purely administrative for a Class I medical device (non-powdered patient examination glove), indicating FDA clearance based on substantial equivalence rather than a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested table and study details based on 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.