(191 days)
Sterile Powder Free Nittile Examination Gloves (Blue, Black and White Colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
The provided text is an FDA 510(k) clearance letter for "Sterile Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software medical device) meets acceptance criteria.
The information you've requested typically applies to AI/ML (Artificial Intelligence/Machine Learning) or diagnostic medical devices that require performance evaluation against specific metrics (e.g., sensitivity, specificity, AUC). General medical devices like examination gloves are cleared based on substantial equivalence to predicate devices and meeting established performance standards (e.g., standards for tensile strength, barrier integrity, biocompatibility, sterility) through laboratory testing, not through clinical or reader studies that involve humans interacting with an AI or interpreting medical images.
Therefore, I cannot fulfill your request using the provided text. The document is strictly about the regulatory clearance of a physical medical device (gloves) and does not describe the kind of performance study you are asking about.
§ 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.