(20 days)
A 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.
Powder Free Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Powder Free Latex Exam Gloves, Non-Sterile with Protein Labeling Claim 50 Microgram or Less." It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance in the context of a statistical study with sample sizes, expert ground truth, or an MRMC study.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device's clearance is based on its substantial equivalence to a predicate device already on the market, not on a standalone performance study with specific acceptance criteria that are detailed in this document.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on "substantial equivalence."
§ 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.