(302 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) This device is not intended to be used as a chemical barrier.
Textured Powder Free Nitrile Examination Gloves (Blue color) with SAP (Super Absorbent Polymer), Textured Powder Free Latex Examination (Natural color) with SAP (Super Absorbent Polymer)
I am sorry, but the provided text is a 510(k) clearance letter for medical examination gloves and does not contain information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the given document.
§ 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.