(118 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, with Protein Claim
This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder-Free, with Protein Claim."
Based on the provided text, there is no information available regarding the acceptance criteria for a device's performance, nor any study proving the device meets said criteria.
The document is an FDA letter acknowledging receipt and review of the 510(k) submission, and confirming that the device, an examination glove, is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.
Therefore, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness as these details are not present in the provided text.
§ 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.