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510(k) Data Aggregation
(224 days)
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.
The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Gloves. This document describes the substantial equivalence of the subject device to a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/software as a medical device (SaMD) or any comparative effectiveness study with human readers improving with AI assistance.
Therefore, many of the requested points related to AI/SaMD performance, ground truth establishment for AI training/testing, MRMC studies, expert adjudication, and effect sizes are not applicable within the context of this document.
This document focuses on proving the physical and chemical properties of a medical glove meet established ASTM and ISO standards for safety and effectiveness, similar to a legally marketed predicate device.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comprehensive table outlining the acceptance criteria (standards) and the reported performance of the Powder Free Nitrile Gloves.
| Characteristic | Standard/Acceptance Criteria (ASTM/ISO) | Reported Device Performance |
|---|---|---|
| Dimension (Small) | ASTM D6319-19 | |
| Length | $\geq$220mm | 246mm |
| Width | 80±10mm | 86.4mm |
| Thickness Finger | $\geq$0.05mm | 0.11mm |
| Thickness Palm | $\geq$0.05mm | 0.08mm |
| Dimension (Medium) | ASTM D6319-19 | |
| Length | $\geq$230mm | 243mm |
| Width | 95±10mm | 96.9mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.09mm |
| Dimension (Large) | ASTM D6319-19 | |
| Length | $\geq$230mm | 255mm |
| Width | 110±10mm | 106mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.09mm |
| Dimension (X-Large) | ASTM D6319-19 | |
| Length | $\geq$230mm | 251mm |
| Width | 120±10mm | 116mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.08mm |
| Physical Properties | ASTM D6319-19 | |
| Before Aging: Tensile Strength | $\geq$14MPa | 34.56MPa |
| Before Aging: Ultimate Elongation | $\geq$500% | 556% |
| After Aging: Tensile Strength | $\geq$14MPa | 36.34MPa |
| After Aging: Ultimate Elongation | $\geq$400% | 485% |
| Freedom from Pinholes | ASTM D5151-19, Inspection level: G-1, AQL=2.5 | Pass, no water leakage, Passed Standard Acceptance Criteria |
| Residual Powder | ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) | Meets |
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