(65 days)
For examination purposes for personnel and similar personnel to prevent contamination between health care worker and the patient's body, fluids and waste.
Powder-Free Latex Examination Glove (Polymer-Coated)
This document is a 510(k) clearance letter from the FDA for medical gloves (Powder-Free Latex Examination Glove). It does not contain information about acceptance criteria or a study proving device performance as it is a regulatory clearance document based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot fulfill your request 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.