(98 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 patient.
Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the ROYAL SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ||
| X-Small (Width) | 70 mm +/- 10 mm | 70 - 75 mm |
| Small (Width) | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium (Width) | 90 mm +/- 10 mm | 90 - 97 mm |
| Large (Width) | 100 mm +/- 10 mm | 105 - 100 mm |
| Length (All Sizes) | 230 mm minimum | 240 mm minimum |
| Thickness - Finger | 0.08 mm minimum | 0.08 mm minimum |
| Thickness - Palm | 0.08 mm minimum | 0.08 mm minimum |
| Physical Properties | ||
| Tensile Strength (Before Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile) | 15.6 MPa |
| Tensile Strength (After Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile) | 14.5 MPa |
| Ultimate Elongation (Before Aging) | 700% (ASTM D3578-95); 500% (ASTM Draft Nitrile) | 650% (Meets ASTM Draft Nitrile, does not meet ASTM D3578-95) |
| Ultimate Elongation (After Aging) | 500% (ASTM D3578-95); 400% (ASTM Draft Nitrile) | 575% |
| Water Tight Test | Meets FDA Water Leak Test Requirements (implied: very low leakage rate, typically |
§ 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.