(341 days)
The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
The gloves are coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.
This document is a 510(k) premarket notification for a medical device (Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of AI performance. Therefore, I cannot provide details on AI acceptance criteria, sample sizes for AI tests, expert qualifications, or MRMC studies.
However, I can extract the acceptance criteria and device performance for the glove itself, as per the submitted documentation.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets Standard Requirements |
| Physical Properties (Before/After Aging) | ASTM D6319-10 | Meets Standard Requirements |
| Freedom from pinholes | ASTM D6319-10 / ASTM D5151-11 | Meets Standard Requirements |
| Biocompatibility (Primary Skin Irritation in Rabbits) | ISO 10993-10:2010 | Not a skin irritant under the conditions of study. |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 | Not a contact sensitizer under the conditions of the study. |
| Powder Residue | (Implied by standard and predicate) | Meets Standard Requirements |
§ 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.