(58 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance of "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue)" and "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)" as detailed in the K993133 510(k) submission.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (Cashmere Powdered Nitrile Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=4.0% | Pass GI AQL=4.0% |
| Length (mm) - Min. for all sizes | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) - Size XS | - | 75 - 78 |
| Palm width (mm) - Size S | 80 +/- 10 | 82 - 88 |
| Palm width (mm) - Size M | 95 +/- 10 | 92 - 98 |
| Palm width (mm) - Size L | 111 +/- 10 | 102 - 108 |
| Palm width (mm) - Size XL | - | 111 - 115 |
| Thickness (mm) - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| Thickness (mm) - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| Before Aging: | ||
| Tensile Strength (Mpa) Before Aging | Min 14 | 30.4 |
| Ultimate Elongation (%) Before Aging | Min 500 | 640 |
| After Aging: | ||
| Tensile Strength (Mpa) After Aging | Min 14 | 30.9 |
| Ultimate Elongation (%) After Aging | Min 500 | 610 |
| 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.