(67 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-free Latex Examination Gloves with Protein Labeling Claim (50 micrograms OR LESS)
This document is a 510(k) premarket notification for Glovco Powder-Free Latex Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence, along with the device's indications for use.
Therefore, I cannot provide the requested information about acceptance criteria and a study from the supplied 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.