(47 days)
The powder-free 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.
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.
This document describes the acceptance criteria and study results for the AMADEX Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|---|
| Dimensions | ASTM D 6319-10 | ||||
| Length | To determine the length of the gloves | Min 230 mm (All Sizes) | >230 mm (Passes) | Same | |
| Width (XS) | 70 ± 10 mm | 76 ± 3 mm | Same | ||
| Width (S) | 80 ± 10 mm | 84 ± 3 mm | Same | ||
| Width (M) | 95 ± 10 mm | 94 ± 3 mm (Also reported as 98 ± 2 mm, which passes 95 ± 10 mm) | Same | ||
| Width (L) | 110 ± 10 mm | 105 ± 3 mm | Same | ||
| Width (XL) | 120 ± 10 mm | 113 ± 3 mm | Same | ||
| Physical Properties | ASTM D 6319-10 | To determine the physical properties (Tensile strength and Elongation) | |||
| Tensile Strength (Before Aging) | 14 Mpa min | 24.5 Mpa (Passes) (Also reported as 14 Mpa in comparison table) | Same | ||
| Ultimate Elongation (Before Aging) | 500% min | 500% (Implied, as result is 14 Mpa and 500% in comparison table) | Same | ||
| Tensile Strength (After Aging) | 14 Mpa min | 14 Mpa (Implied) | Same | ||
| Ultimate Elongation (After Aging) | 400% min | 400% (Implied) | Same | ||
| Thickness | ASTM D 6319-10 | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min | Palm: 0.09 mm (Passes), Finger: 0.12 mm (Passes) | Same |
| Powder Free | ASTM D 6319-10, D 6124-06 | To determine the amount of residual powder and non-powder solids found on gloves |
§ 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.