(15 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.
Powderfree( Polymer coated ) patient latex examination gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Southland Powder-Free (Polymer-Coated) Latex Examination Gloves." This document does not contain any information about acceptance criteria or studies that prove the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It mentions the product code (LYY) and regulatory class (I), and states the indications for use.
Therefore, I cannot provide the requested information.
§ 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.