(191 days)
FirstLine Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free – Steel Blue Color) is a disposable patient examination glove that 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.
Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color)
This document is an FDA 510(k) clearance letter for Double Polymer Coated, Nitrile Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but it does not provide performance data or details of a study.
Therefore, I cannot provide the requested information based on 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.