(192 days)
Thermoplastic Polyethylene Examination (TPE) Glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding a Thermoplastic Polyethylene Examination (TPE) Glove. It confirms that the device is substantially equivalent to a legally marketed predicate device.
The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. This type of submission is for a physical medical device (gloves), not a software/AI device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets based on the provided text. This information is not relevant to a 510(k) submission for examination gloves.
§ 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.