(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 |
§ 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.