(60 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.
Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | Width (mm) | |
| Width (Small) | 80-90 mm | 82-88 |
| Width (Medium) | 90-100 mm | 94-98 |
| Width (Large) | 100-110 mm | 103-109 |
| Width (X-Large) | 110-120 mm | 114-117 |
| Thickness (mm) | ||
| Fingertip | ≥0.05 mm (ASTM D 5250-06) | 0.09-0.10 |
| Palm | ≥0.08 mm (ASTM D 5250-06) | 0.10-0.11 |
| Physical Properties | ASTM D 5250-06 (Reapproved 2015) | |
| Tensile Strength (Before & After aging) | ≥11 MPa | 15-22 MPa |
| Elongation Rate (Before & After aging) | ≥300% | 350-420% |
| Freedom from Pinholes | Holes at Inspection Level I AQL2.5 (21 CFR 800.20, ASTM D5250-06, ASTM D5151-19) | Met Acceptance Criteria; Holes at Inspection Level I AQL2.5 |
| Powder Residual |
§ 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.