(94 days)
The Nitrile Examination Glove (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Nitrile Examination Glove (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
This document is a 510(k) Pre-market Notification for a medical device, specifically a Nitrile Examination Glove. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. The information provided outlines the acceptance criteria and the results of non-clinical tests to prove the device meets these criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes | No water leakage is inspected from 125 samples |
| ASTM D6124 | Determine the powder residue for powder free 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.