(93 days)
The Viny/Nitrile Blend Exam 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/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device called "Vinyl/Nitrile Blend Exam Glove." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting studies validating an AI/ML driven medical device's performance against detailed acceptance criteria for diagnostic or prognostic tasks.
Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical glove submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for manufacturing quality and safety, not for diagnostic performance evaluation of an AI model.
However, I can extract the relevant information from the provided document regarding its physical and biological performance acceptance criteria and results.
Here's the breakdown based on the provided text, focusing on the device itself (medical glove) and its physical/biocompatibility characteristics, not an AI system.
Acceptance Criteria and Device Performance for Vinyl/Nitrile Blend Exam Glove
This document describes the non-clinical testing performed to demonstrate that the Vinyl/Nitrile Blend Exam Glove meets established safety and performance standards for patient examination gloves. It is important to note that this is not an AI/ML device, and thus most AI/ML-specific study design criteria (e.g., ground truth, reader studies, AI performance metrics) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Characteristic/Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | ||
| Length | S/M/L/XL: ≥230 mm | >230 mm / Pass | |
| Width | S: 85±5 mm; M: 95±5 mm; L: 105±5 mm; XL: 115±5 mm | S: 82-88 mm / Pass; M: 90-98 mm / Pass; L: 100-106 mm / Pass; XL: 110-117 mm / Pass | |
| Thickness (Finger) | ≥0.08 mm | 0.10-0.14 mm / Pass | |
| Thickness (Palm) | ≥0.08 mm | 0.08-0.10 mm / Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content |
§ 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.