(48 days)
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree, Blue Nitrile Examination Glove
This document is an FDA 510(k) clearance letter for examination gloves. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML devices or diagnostic tools.
Therefore, I cannot provide the requested information based on the provided text. The letter primarily confirms that the gloves are "substantially equivalent" to predicate devices already on the market, implying they meet existing standards for such products (e.g., for barrier protection, freedom from holes, biocompatibility, etc.), which are established through general controls provisions. However, these specific criteria and their associated testing results are not detailed in this clearance letter.
§ 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.