(74 days)
The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.
Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for "POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS PER GRAM OF GLOVE)".
It's important to note that this is a medical device submission for examination gloves, not an AI/Software as a Medical Device (SaMD) submission. Therefore, many of the typical questions related to AI studies (like MRMC, training set details, expert qualifications for AI ground truth) are not applicable to this type of device. The focus here is on physical and chemical performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standards / Acceptance Criteria | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-01 | Meets |
| Physical Properties | ASTM D 3578-01 | Meets |
| Freedom from Pinholes | ASTM D 3578-01 | Meets |
| Freedom from Pinholes | FDA 21 CFR 800.20 | Meets |
| Powder Free | ASTM D 6124-97 |
§ 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.