(38 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Latex Examination Glove
This document is a 510(k) clearance letter from the FDA for a medical device: "HWA (and)Silktex Powder-Free Latex Examination Glove". It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information (device performance metrics, study design, ground truth establishment, sample sizes, etc.) is typically found in the accompanying 510(k) summary or detailed submission, not in the clearance letter itself.
Therefore, I cannot provide the requested information based solely on the text provided. The document confirms market clearance but does not detail the technical performance characteristics or the studies behind them.
§ 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.