(175 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 proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance (K191292) |
|---|---|---|
| Dimensions - Length | ASTM D 5250-06 (Reapproved 2011): ≥ 230mm | 233-241mm |
| Dimensions - Width | ASTM D 5250-06 (Reapproved 2011): | |
| Small 80-90 mm | ||
| Medium 90-100mm | ||
| Large 100-110mm | ||
| X large 110-120 mm | 84-88 mm | |
| 94-98 mm | ||
| 103-109 mm | ||
| 114-117 mm | ||
| Dimensions - Thickness | ASTM D 5250-06 (Reapproved 2011): | |
| Fingertip ≥0.05mm | ||
| Palm ≥0.08mm | Fingertip: 0.08-0.11mm | |
| Palm: 0.10-0.11mm | ||
| Physical Properties (Tensile Strength) | ASTM D 5250-06 (Reapproved 2011): ≥11MPa (Before & After aging) | 15-17 MPa (for "Physical Properties") |
| Physical Properties (Elongation Rate) | ASTM D 5250-06 (Reapproved 2011): ≥300% (Before & After aging) | 350-390% (for "Physical Properties") |
| Freedom from Pinholes | ASTM D5151-06 (Reapproved 2011): Holes at Inspection Level I, AQL2.5, Act/Re: 10/11 | Water leakage test: 3 noncompliance is allowed (This is a different test/criterion reported in the comparison table, but within the "similar" category for pinholes). The detailed result for the ASTM D5151-06 specific criterion is not explicitly stated as "Pass" or "Fail" in the result column, but the overall "similar" comparison implies conformity. |
| Powder Residual | ASTM D6124-06 (Reaffirmation 2011): |
§ 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.