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The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Disposable Nitrile Powder-Free Examination 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.

AI/ML Overview

Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.

Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.

Here's the relevant information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.

Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:

Test	Methodology / Standard	Purpose	Acceptance Criteria	Reported Performance/Results
Biocompatibility
Irritation & Skin Sensitization	ISO 10993-10:2010	Assess possible contact hazards from chemicals, which may produce skin and mucosal irritation, eye irritation or skin sensitization.	Skin Sensitization Test: Provided grades less than 1, otherwise sensitization.Skin Irritation Test: Primary irritation index: 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe).	Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs observed.Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible.
In Vitro Cytotoxicity	ISO 10993-5:2009	Assess the in vitro cytotoxicity of medical devices.	Viability reduced to <70% of the blank indicates cytotoxic potential.	Viab.% of 100% test article extract is 21.0%. The proposed device has potential toxicity to L-929 in the MTT method. (Note: Despite this, it was cleared, likely due to subsequent systemic toxicity testing and the nature of glove contact.)
Systemic Toxicity	ISO 10993-11:2017	Evaluate the potential for medical device materials to cause adverse systemic reactions.	Within 72 h, if the toxicosis response of testing group is not greater than that of control group, the testing sample is acceptable.	No evidence of systemic toxicity from the extract.
Physical/Performance Properties
Residual Powder on Medical Gloves	ASTM D6124-06 (Reapproved 2017)	Determine the amount of residual powder found on medical gloves (for powder-free distinction).	Powder residue limit of 2.0 mg.	0.09-0.11 mg/glove. (Meets criterion as it is well below 2.0mg)
Detection of Holes in Medical Gloves	ASTM D5151-06 (Reapproved 2015)	Cover the detection of holes in medical gloves.	Sample number: 125 gloves. AQL (Acceptable Quality Limit) = 2.5. Criterion ≤7 gloves for water leakage.	No glove water leakage found.
Specifications for Nitrile Exam Gloves	ASTM D6319-10 (Reapproved 2015)	Covers certain requirements for nitrile rubber gloves used in medical examinations and procedures.	Dimensions:- S: width 80±10mm, length ≥220 mm- M: width 95±10mm, length ≥230 mm- L: width 110±10mm, length ≥230 mm- XL: width 120±10mm, length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mmPhysical properties:- Before aging: Tensile strength ≥14MPa, Ultimate Elongation ≥500%- After Accelerated Aging: Tensile strength ≥14MPa, Ultimate Elongation ≥400%	Dimensions (across multiple lots):- S: width 82-86 mm, length 245-255 mm- M: width 91-96 mm, length 245-256 mm- L: width 101-110 mm, length 252-261 mm- XL: width 111-120 mm, length 250-262 mm (All reported dimensions meet or exceed the min/range, considering tolerance analyses further down the document).Thickness (across multiple lots): Finger 0.11-0.12 mm, Palm 0.07-0.08 mm (All meet or exceed the minimum).Physical properties (across multiple lots):- Before aging: Tensile strength 15.2-24.4 MPa, Ultimate Elongation 525.655% - 798.544% (All meet or exceed required minimums).- After Accelerated Aging: Tensile strength 14.0-18.7 MPa, Ultimate Elongation 578.552% - 745.388% (All meet or exceed required minimums).

Study Details (Non-Clinical Performance Testing):

This document describes non-clinical performance testing of a physical device (examination gloves), not a study of an AI algorithm or human reader performance. Therefore, most of the requested fields are not applicable.

Sample size used for the test set and the data provenance:
- Freedom from Holes: 125 gloves. No specific country of origin is mentioned for the test samples; it's implied they are samples of the manufactured gloves. The testing is prospective as it's part of the product characterization for market submission.
- Other tests (Biocompatibility, Physical properties): Sample sizes are not explicitly stated for individual tests but are implied to be sufficient for compliance with the respective standards (e.g., ISO, ASTM). The data provenance is testing conducted by the manufacturer (Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.) or its contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for device performance is established by standardized test methodologies and their objective measurements, not by expert consensus or interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human interpretation study.
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:
- Not applicable. This device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is defined by adherence to established international and national standards (ASTM, ISO) for material properties, dimensions, and biological safety. This is based on objective measurements and laboratory testing results.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model. The manufacturing process is implicitly "trained" over time to produce consistent results that meet standards.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.

In summary, this FDA 510(k) submission for examination gloves demonstrates substantial equivalence to a predicate device, primarily through non-clinical laboratory testing that shows compliance with relevant performance and safety standards. The regulatory pathway is not driven by AI model validation or human reader performance studies.

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