(161 days)
The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The proposed device, Nitrile Examination Gloves (Blue, Violet) 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 and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
This document describes the performance testing for Nitrile Examination Gloves (Blue, Violet). Here's a breakdown of the acceptance criteria and study details:
Acceptance Criteria and Reported Device Performance
Device: Nitrile Examination Gloves (Blue, Violet)
Purpose: Non-sterile disposable device worn to prevent contamination between patient and examiner.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from Holes | Freedom from holes AQL 2.5 | Blue Color: No water leakage inspected from 200 samples |
| Violet Color: No water leakage inspected from 200 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.