FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

mCare® Powder-free Nitrile Blue Examination Gloves are substantially equivalent to the Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

AI/ML Overview

This document describes the premarket notification (510(k)) for the mCare® Powder-free Nitrile Blue Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, as clinical performance data is not required for this type of device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text includes a table (on page 4 and 5) that compares the characteristics, standards, and device performance of the mCare® Powder-free Nitrile Blue Examination Gloves ("Current") against a predicate device ("Predicate") and relevant ASTM standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE (Current Device - K172930)
Dimensions	ASTM D6319-10	Length min 230 mm.
Width min 95 ± 10
Physical Properties	ASTM D6319-10	Before Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 500 %

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each test (e.g., for physical properties, watertightness, biocompatibility). It references ASTM standards, which would dictate the sampling plans. The data provenance is associated with Mercator Medical (Thailand) LTD., located in Thailand, suggesting the tests were conducted or overseen by them. The studies are for a new device seeking clearance, so they are inherently prospective from the device's perspective given the timeframe of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This type of information (number and qualifications of experts) is not relevant or typically included for the testing of examination gloves. The "ground truth" for these tests are objective measurements against established engineering standards (ASTM and ISO).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where there's subjective interpretation by multiple human readers (e.g., radiologists reviewing images). For the performance testing of examination gloves, the tests involve objective measurements against predefined standards. Therefore, an adjudication method is not applicable and not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is completely irrelevant for this device. This device is an examination glove, not an AI-powered diagnostic tool, and it does not involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also not applicable. The device is a physical examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance criteria listed in the table is based on established engineering and material science standards, specifically:

ASTM D6319-10 (for dimensions, physical properties, thickness, material)
ASTM D6319-06 (for powder-free and watertightness)
ISO 10993-10:2010 (E) and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for biocompatibility - primary skin irritation and dermal sensitization)
Medical Glove Guidance Manual - Labeling (for size and single use)

These standards define the acceptable range or threshold for each characteristic based on scientific and industry consensus regarding what constitutes a safe and effective examination glove.

8. The sample size for the training set

There is no "training set" in the context of an examination glove's performance testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

Regulation Number and Section

§ 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.