(124 days)
Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Nitra-Touch™ examination gloves
This document describes the acceptance criteria and performance of Nitra-Touch™ examination gloves, specifically focusing on their compliance with ASTM standards and other relevant criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578, Except Ultimate Elongation: Original 500% minimum, Aged 400% minimum | Meets ASTM D 3578, Except Ultimate Elongation meets specifications described under Attachment II (Specific percentages for Nitra-Touch™'s performance are not provided in the text beyond stating it "meets specifications described under Attachment II" - further detail would be in the attachment). |
| Freedom from holes | Meets described test in Attachment V (and implicitly, FDA hole requirements) | Powder-Free: Meets described test in Attachment V; Meets ASTM D 5151 |
| Residual Powder | Not more than 2 mg residue by mass (for powder-free gloves) | Not more than 2 mg residue by mass |
| Tensile Strength | Measured against ASTM D 5250 and ASTM D 3578 for vinyl (10.5 MPa) | 60% higher than vinyl (synthetic) examination gloves; Nitra-Touch™ = 17.1 MPa (ASTM D 5250) |
| Puncture Resistance | Measured against ASTM D 120-87 for Blue Nitrile (929 lbf/in) and Vinyl (184 lbf/in) | Eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves; Nitra-Touch™ = 1625 lbf/in |
| Glutaraldehyde Resistance | ASTM T F739-91 (Breakthrough Time and Permeation Rate) | Breakthrough Time = >480 minutes; Permeation Rate = |
§ 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.