(153 days)
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, 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, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, 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 and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Disposable Nitrile Examination Gloves.
Important Note: This document pertains to the clearance of a medical device – specifically disposable nitrile examination gloves. The concepts of "AI models," "human readers," "effect size," "multi-reader multi-case (MRMC) comparative effectiveness studies," "standalone algorithms," and "ground truth establishment for training sets" as typically applied to AI/ML medical devices do not apply to this product. This submission focuses on the physical and performance characteristics of the gloves themselves compared to a predicate device.
Therefore, the answers to several of your requested points will be "Not Applicable" or refer to standard laboratory testing rather than AI/ML model validation.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Worst Case/Representative) |
|---|---|---|---|
| ASTM D5151 | Freedom from Holes | AQL 2.5 | Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5) |
| Purple-Blue Color: No water leakage inspected from 200 samples (Meets AQL 2.5) | |||
| ASTM D6124 | Residual Powder 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.