(100 days)
An examination glove is a disposable device intended for medical purposes "An examinon Eroro is a carperation or finger to prevent contamination between patient and examiner."
Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free,Less than 50mcg/gram Total Protein
This document is a 510(k) clearance letter from the FDA for a medical device: Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free, Less than 50mcg/gram Total Protein.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is primarily an FDA letter clearing the device for market based on substantial equivalence to a predicate device. It defines the product and its intended use, but it does not detail any performance studies, test results, or the methodologies used to establish such results.
Therefore, I cannot provide the requested information 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.