(87 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
This document is a 510(k) Summary for Synthetic Vinyl Examination Gloves, a Class I medical device. It details the device's characteristics and its equivalence to a predicate device, supported by non-clinical testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D5250) | ||
| Length (mm) | ≥ 230 | ≥ 230 / Pass (for all sizes) |
| Width (mm) | XS: 75 ± 5 | |
| S: 85 ± 5 | ||
| M: 95 ± 5 | ||
| L: 105 ± 5 | ||
| XL: 115 ± 5 | XS: 78-79 / Pass | |
| S: 87-88 / Pass | ||
| M: 95-98 / Pass | ||
| L: 103-107 / Pass | ||
| XL: 116-117 / Pass | ||
| Thickness (mm) - Finger | ≥ 0.08 | 0.08-0.09 / Pass |
| Thickness (mm) - Palm | ≥ 0.08 | 0.10 / Pass |
| Watertightness Test for Detection of Holes (ASTM D5151) | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks / Pass |
| Powder Content (ASTM D6124) | Meet the requirements of 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.