Search Results

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves (YK0001). It addresses the substantial equivalence of the device to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a predicate device, often through performance testing against established standards, rather than through extensive clinical trials for new medical technologies.

Therefore, the study design described in the prompt, addressing AI performance, MRMC studies, and detailed ground truth establishment, is not applicable to this specific medical device (examination gloves). The document details the physical and chemical properties of the gloves and their compliance with relevant ASTM and ISO standards.

Here's the information extracted that aligns with the prompt's request for acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI medical device (Nitrile Powder Free Examination Gloves). The acceptance criteria are based on established national and international standards for medical gloves.

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319	Physical Dimensions Test	Length (mm):- Small: ≥230mm- Medium: ≥230mm- Large: ≥230mm- X large: ≥230mmWidth (mm):- Small: 85±10mm- Medium: 95±10mm- Large: 110±10mm- X large: 115±10mmThickness (mm) Finger:- Small: ≥0.05mm- Medium: ≥0.05mm- Large: ≥0.05mm- X large: ≥0.05mmThickness (mm) Palm:- Small: ≥0.05mm- Medium: ≥0.05mm- Large: ≥0.05mm- X large: ≥0.05mm	Length (mm):- Small: 231-238/Pass- Medium: 244-248/Pass- Large: 245-249/Pass- X large: 240-244/PassWidth (mm):- Small: 85-86/Pass- Medium: 96-97/Pass- Large: 106-108/Pass- X large: 113-114/PassThickness (mm) Finger:- Small: 0.097-0.111/Pass- Medium: 0.110-0.131/Pass- Large: 0.110-0.129/Pass- X large: 0.116-0.128/PassThickness (mm) Palm:- Small: 0.064-0.068/Pass- Medium: 0.065-0.069/Pass- Large: 0.060-0.065/Pass- X large: 0.059-0.066/Pass
ASTM D5151	Watertightness Test for Detection of Holes	No water leakage (Inspection Level I, AQL 2.5, as per ASTM D6319-19 and 21 CFR 800.20)	0/125/Pass
ASTM D6124	Powder Content	< 2mg of residual powder	0.3-0.4mg/Pass
ASTM D6319 / ASTM D412	Physical Properties	Before Aging:- Tensile Strength ≥14MPa- Ultimate Elongation ≥500%After Aging:- Tensile Strength ≥14MPa- Ultimate Elongation ≥400% (AQL 4.0 requirement)	Meet the requirements of ASTM D6319 AQL 4.0 for both Before and After Aging.
ISO 10993-5	Cytotoxicity	Non-cytotoxicity	Under conditions of the study, device extract is cytotoxic (This appears to be a typo in the original document, it should likely state "non-cytotoxic" given the "Pass" status implied by the ISO 10993-1, 10993-5, 10993-10, 10993-11 compliance and overall "Pass" in the summary table). Assuming the intent was "non-cytotoxic", as the overall conclusion states the device meets requirements. The summary of biocompatibility states "non irritant , non sensitizer and non Systemic Toxicity". The table states "device extract is cytotoxic", but also says "pass". Given the conflict, and that it's a 510K for a Class I general hospital device, it's highly likely it means "non-cytotoxic".
ISO 10993-11	Acute Systemic Toxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant/ Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer./ Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each physical/biocompatibility test.

For Watertightness Test (ASTM D5151): The result "0/125/Pass" implies a sample size of 125 gloves were tested, and 0 failed, indicating all passed the watertightness test.
Data Provenance: The document does not specify the country of origin of the data for these tests beyond the manufacturer being located in Hebei Province, China. The tests are non-clinical (laboratory-based) and conducted against international standards (ASTM, ISO). They are retrospective in the sense that the results were generated prior to the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The ground truth for this device is based on objective, quantifiable measurements against established engineering and biocompatibility standards (ASTM, ISO), not on expert subjective interpretation or consensus of medical images.

4. Adjudication Method for the Test Set

This section is not applicable. As the tests are based on objective measurements against standards, there is no need for an adjudication method as would be used in expert consensus for image interpretation.

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

This section is not applicable. This is a non-AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This is a non-AI device.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, quantifiable measurements and adherence to recognized performance standards (ASTM D6319, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993 series).

8. The Sample Size for the Training Set

This section is not applicable. This is a non-AI medical device; therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. There is no training set for this type of device.

Ask a Question

Ask a specific question about this device

Page 1 of 1