(336 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided text details the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description of an AI-powered device. Therefore, much of the requested information regarding AI device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not applicable or present in this document.
However, I can extract the acceptance criteria and reported device performance for these medical gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D5151-06 (Reapproved 2011) | Meets (AQL 2.5) |
| Powder Residual | ASTM D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011) | 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.