(231 days)
The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.
The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.
However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.
Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S/M/L/XL: ≥230 | Length (mm): >230/Pass |
| Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | Width (mm): S: 83-85/Pass; M: 94-96/Pass; L: 103-106/Pass; XL: 113-115/Pass | ||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Thickness (mm): Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
§ 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.