(66 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Polymer Coated, Powder Free, Nitrile Examination Gloves, Blue Color
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document only confirms that the specified polymer-coated, powder-free, nitrile examination gloves from PT. Smart Glove Indonesia are substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given text.
The provided text focuses on the regulatory clearance process for a medical device (examination gloves) by the FDA. It does not contain the technical details of device performance, acceptance criteria, or study methodologies that would be needed to answer your specific questions.
§ 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.