(173 days)
Latex Examination Glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Latex Examination Gloves (Powdered)
The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves (Powdered)". This type of document is a regulatory approval for a medical device and does not contain the detailed technical study information that would describe acceptance criteria and device performance in the way requested for AI/ML or diagnostic devices.
Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these types of studies are not typically conducted or reported in a 510(k) summary for general-purpose physical devices like examination gloves. The 510(k) pathway for such devices primarily focuses on demonstrating substantial equivalence to a predicate device, often through engineering specifications, material properties, and basic performance tests (e.g., integrity, strength), rather than clinical performance metrics that would involve complex statistical analyses and expert adjudication.
§ 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.