(95 days)
The Disposable Vinyl Examination Gloves are 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 clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Physical Properties | ||
| Tensile Strength (Before Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (Before Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Tensile Strength (After Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (After Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Meets the requirements (AQL=2.5) |
| Powder Content |
§ 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.