(44 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.
Powder Free Nitrile Examination Gloves. (Green and Blue)
This is a 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves (Green and Blue)" by FLEXITECH SDN. BHD. The document is an FDA letter stating substantial equivalence and an "Indication For Use" statement. It does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. Therefore, I cannot generate the requested information based on the provided text.
The document is primarily a regulatory communication outlining the FDA's decision to permit the marketing of the device due to substantial equivalence to a legally marketed predicate device. It briefly mentions the intended use of the gloves but does not delve into performance metrics or study data.
§ 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.