(51 days)
This glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
This document is a 510(k) premarket notification letter from the FDA to APL Products Sdn. Bhd. for their "Online Powder Free, Latex Examination Gloves". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA). Substantial equivalence is generally based on demonstrating the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics and performance data to that of the predicate, but the specific acceptance criteria and detailed study results are not provided in this document.
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.