(31 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Green Nitrile Examination Gloves
This document is an FDA 510(k) clearance letter for Powdered Green Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance, and therefore, the requested table and study details cannot be extracted from the provided text.
The document states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the device's indications for use and compliance with general controls provisions of the Act, including good manufacturing practices.
To answer your request, information about performance testing (such as barrier integrity, strength, biocompatibility, etc.) would need to be present in the original 510(k) submission, which is not provided here.
§ 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.