(214 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
This document is a 510(k) Premarket Notification from the FDA regarding "Vinyl Exam Gloves, Powder Free, Clear". It's a regulatory submission for a medical device and does not describe an AI/ML powered device or a study related to AI/ML.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device. The document is about physical properties and biocompatibility of examination gloves, not an AI system.
§ 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.