(259 days)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove contains 50 micrograms or less of total water extractable protein per gram.
CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions
Non-sterile, Powder-Free Latex Examination Glove
This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.
The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based device.
§ 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.