(83 days)
This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner.
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
This is a 510(k) premarket notification letter from the FDA to SinetiMed Latex Sdn. Bhd. for their NitriKleen-Nitrile Examination Glove Powder-Free surgical gloves. The letter states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information on acceptance criteria, device performance, study details, or ground truth establishment. This is a regulatory clearance letter, not a study report. Therefore, I cannot extract the requested information from this document.
§ 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.