(196 days)
The Disposable nitrile gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.
This document is a 510(k) submission for disposable nitrile gloves. It is primarily concerned with establishing substantial equivalence to a predicate device, not with a clinical study of AI performance. Therefore, many of the requested elements regarding AI model acceptance criteria and study design are not applicable to this document.
However, I can extract information related to the device's performance acceptance criteria and how they were proven in a non-clinical setting.
Here's the breakdown based on the provided document:
Device: Disposable nitrile gloves (K223280)
Purpose of the document: To demonstrate substantial equivalence to a legally marketed predicate device (K212924) and obtain FDA clearance for marketing.
Acceptance Criteria and Reported Device Performance
The device performance is evaluated against established ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Pass | ||
| - Length (mm) | >230 | >230 | Pass | |
| - Width (mm) | S: 85±5 | S: 85 | Pass | |
| M: 95±5 | M: 95 | Pass | ||
| L: 105±5 | L: 105 | Pass | ||
| XL: 115±5 | XL: 115 | Pass | ||
| - Thickness (mm) (Finger) | ≥0.05 | 0.09-0.15 | Pass | |
| - Thickness (mm) (Palm) | ≥0.05 | 0.06-0.07 | Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Met the requirements | Pass |
| ASTM D6124 | Powder Content |
§ 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.