(25 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Natural Latex Examination Gloves with Protein Claim (50mcg or less EXTRACTABLE PROT
This document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free with Protein Labeling Claim, (50 mcg or less)". It does not contain information about the acceptance criteria and study proving device meets the acceptance criteria in the format requested.
The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It details general regulatory provisions and contact information for further inquiries.
Therefore, I cannot provide the requested table and study information based on the given input.
§ 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.