(55 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient.
Powdered Latex Examination Gloves with Protein and Powder Claim (100 MICROGRAMS OF LESS)
The provided text is a 510(k) pre-market notification letter from the FDA regarding "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less)". This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, or performance results of a device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly for regulatory approval of a medical device based on substantial equivalence.
§ 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.