(69 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs
Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
The provided text is a U.S. FDA 510(k) clearance letter for "Powder-Free Latex Examination Gloves with Aloe and Protein Claim, Tested for Use with Chemotherapy Drugs". This document is a regulatory communication and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed, but it does not detail the technical studies that would typically define acceptance criteria and performance.
§ 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.