(112 days)
The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for "Disposable Nitrile Gloves." This document primarily focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving that it meets acceptance criteria for an AI/algorithm-based diagnostic device through a study with human readers.
Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for training sets, and the number and qualifications of experts for ground truth, is not applicable to this document.
The document describes performance testing for a physical medical device (gloves) against established standards for physical properties and biocompatibility.
Here's an analysis based on the information available in the document, framed to address the prompt's structure where possible, but highlighting the inapplicability of AI-specific criteria.
Analysis of Acceptance Criteria and Device Performance (for Disposable Nitrile Gloves)
The document, K211781, describes the submission for Disposable Nitrile Gloves. The "acceptance criteria" in this context refer to the performance specifications and safety standards for the physical product, not for an AI/algorithm. The study presented is a series of non-clinical bench tests and biocompatibility assessments demonstrating the gloves meet these standards and are substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are derived from recognized standards (ASTM and ISO). The reported device performance shows the proposed device meets or exceeds these criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Tests | |||
| ISO 10993-10:2010 (Irritation & Skin Sensitization) | Assess potential contact hazards (skin/mucosal irritation, eye irritation, skin sensitization). | Skin Sensitization: Grades less than 1. Skin Irritation: Primary Irritation Index 0-0.4 (Negligible). | All grades are 0. All animals survived with no abnormal signs. Primary irritation index is 0 (negligible response). |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess in vitro cytotoxicity. | Viability reduced to |
§ 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.