(109 days)
A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner.
Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim ( 200 Micrograms or Less )
The provided text is a 510(k) premarket notification letter from the FDA to a manufacturer of "Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices for its indicated use as a disposable medical device worn on an examiner's hand or finger to prevent contamination.
This document is a regulatory approval letter for a medical device (examination gloves). It does not contain information about the performance criteria, study design, or results of a study as would be relevant for an AI/ML powered medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert involvement. The concept of "acceptance criteria," "test set," "training set," "ground truth," or "multi-reader multi-case (MRMC) comparative effectiveness study" is not applicable to an examination glove in the same way it would be for a diagnostic AI algorithm.
The letter simply states that the device is substantially equivalent to existing devices for its stated indications for use: "A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner."
§ 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.