(28 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.
Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]
This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]". It addresses the regulatory classification and substantial equivalence of the device but does not contain information about acceptance criteria, study details, or device performance metrics as requested.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.
§ 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.