(63 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Ultrasense AF Blue Power-free Nitrile Examination Gloves
This document pertains to the clearance of "Ultrasense AF Blue Power-Free Nitrile Examination Gloves" (K033777). As such, it is a device submission for a physical product (gloves), not a diagnostic AI/ML algorithm or software as a medical device (SaMD).
Therefore, the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for an AI/ML device is not applicable to this document.
The document discusses the substantial equivalence determination for examination gloves based on regulatory requirements for a physical medical device, not a software-based diagnostic tool.
§ 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.