(207 days)
Nitrile Powder Free Patient Examination Gloves, Blue color 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.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile 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 D6319 and ASTM D5151 requirements.
The provided document is a 510(k) summary for Nitrile Powder Free Patient Examination Gloves, Blue Color. This document describes the device's characteristics and its comparison to a predicate device to establish substantial equivalence, not a study performing extensive clinical trials typically associated with AI/ML devices. Therefore, many of the requested criteria regarding AI device performance are not applicable to this submission.
Here's an analysis of the provided information relative to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM and CFR standards.
| Characteristic | Standard/Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 (Before/After aging: Elongation $\ge$ 500%, Tensile Strength $\ge$ 14MPa) | Meets (Elongation: 520-580%, Tensile Strength: 22-34 MPa) |
| Freedom from pinholes | 21 CFR 800.20, ASTM D 5151-06 (Reapproved 2011), AQL 2.5 (Inspection Level I) | Meets |
| Powder Residual | ASTM D 6319-10, ASTM D 6124-06 (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.