(139 days)
ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ELAZ Nitrile Powder Free Examination Glove is non-sterile, single use only, disposable, powder free examination glove. The glove is made of Acrylonitrile-butadiene rubber. The glove is designed to meets the specification of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the performance testing for the ELAZ Nitrile Powder Free Examination Glove, a Class I medical device. The information provided is for a traditional 510(k) submission, confirming substantial equivalence to a predicate device.
It's important to note that this is a medical glove, not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study designs for AI/software-based medical devices (like MRMC studies, expert ground truth adjudication, training/test set provenance for AI, etc.) are not applicable here. The performance evaluation focuses on physical properties, biocompatibility, and compliance with established ASTM and ISO standards for examination gloves.
Here's a breakdown of the provided information, framed within the context of a medical glove substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
The full table from the document (page 6-7) is replicated here, summarizing the acceptance criteria and the test results for the ELAZ Nitrile Powder Free Examination Glove.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19: Physical Dimensions Test (mm) | |||
| Length (mm) | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 (All Pass) | |
| Width (mm) | S: 80±10, M: 95±10, L: 110±10, XL: 120±10 | S: 87-89, M: 99-101, L: 110-113, XL: 112-115 (All Pass) | |
| Finger Thickness (mm) | ≥ 0.05 | S ≥ 0.16, M ≥ 0.15, L ≥ 0.15, XL ≥ 0.13 (All Pass) | |
| Palm Thickness (mm) | ≥ 0.05 | S ≥ 0.11, M ≥ 0.11, L ≥ 0.11, XL ≥ 0.10 (All Pass) | |
| ASTM D5151-19 | Testing for Freedom from holes | AQL 2.5 | Gloves pass AQL 2.5 |
| ASTM D6124-17 | Determine the powder residue for powder free gloves |
§ 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.