(59 days)
The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).
Here's an analysis of the acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Subject Device) |
|---|---|
| Physical Dimensions: | |
| Length (ASTM D5250) | 230mm (XS, S, M, L, XL) min |
| Width (ASTM D5250) | 75mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) ± 5mm |
| Finger Thickness (ASTM D5250) | 0.08mm min |
| Palm Thickness (ASTM D5250) | 0.08mm min |
| Physical Properties: | |
| Tensile Strength Before Aging (ASTM D5250) | 11MPa, min |
| Ultimate Elongation Before Aging (ASTM D5250) | 300% min |
| Tensile Strength After Aging (ASTM D5250) | 11MPa, min |
| Ultimate Elongation After Aging (ASTM D5250) | 300% min |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 |
| Powder Content (ASTM D6124) |
§ 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.