(187 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.
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250-06 (Reapproved 2015) | Dimension (mm) IL S-2 AQL4.0 | ||
| Length | $\geq$ 230 | 233-241 | |
| Width (Small) | 80-90 | 81-89 | |
| Width (Medium) | 90-100 | 92-99 | |
| Width (Large) | 100-110 | 102-109 | |
| Width (X-Large) | 110-120 | 112-119 | |
| Thickness (Fingertip) | $\geq$ 0.05 | 0.09-0.11 | |
| Thickness (Palm) | $\geq$ 0.08 | 0.10-0.11 | |
| ASTM D5250-06 (Reapproved 2015) | Physical Properties IL S-2 AQL4.0 | ||
| Tensile strength | $\geq$ 14MPa (Before & After aging) | 17-25 MPa (implicitly for before & after, as it covers the range) | |
| Elongation (Before aging) | $\geq$ 500% | 560-610% | |
| Elongation (After aging) | $\geq$ 400% | 460-570% | |
| 21 CFR 800.20, ASTM D5250-06 (Reapproved 2015), ASTM D5151-19 | Freedom from pinholes | Waterleakage test: Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. (5 noncompliance is allowed.) | Pass |
| ASTM D5250-06 (Reapproved 2015), ASTM D6124-06 (Reapproved 2017) | 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.