(70 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Non-Sterile Nitrile Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Powdered Non-Sterile Nitrile Examination Gloves" manufactured by TA CHIA RUBBER IND. CORP. LTD.
It does not describe any acceptance criteria or a study that proves the device meets acceptance criteria. The letter simply states that the FDA has reviewed the 510(k) application and determined the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance, not a study report or a description of performance criteria.
§ 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.