(80 days)
A 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
Thermoplastic Elastomer Examination (TPE) Glove
The provided text is related to the FDA's clearance of a medical device, specifically a "Thermoplastic Elastomer Examination (TPE) Glove," as described in K172678.
However, the document is a 510(k) clearance letter and does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical document.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance evaluations with specific acceptance criteria and study designs in the way you've outlined for AI or diagnostic devices.
Therefore, I cannot provide the requested information from this document. The information you're asking for (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typical for the evaluation of AI/ML-based medical devices or complex diagnostic systems, not for a Class I patient examination glove which is typically evaluated based on manufacturing quality, integrity, and barrier properties, often using standardized test methods.
§ 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.