(38 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)."
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's functional performance metrics.
Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.
§ 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.