(68 days)
Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.
Powdered Green Latex Examination Glove
This document is a 510(k) premarket notification letter from the FDA regarding "Green Powdered Latex Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, or clinical trial details. It is a regulatory approval letter based on "substantial equivalence" to existing devices, not a report on a new device's performance against specific criteria.
Therefore, I cannot provide the requested information from this text. The questions you've asked typically relate to detailed technical or clinical studies supporting a device's efficacy and safety, which are not present in this regulatory correspondence.
§ 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.