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Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided information is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". This document describes the device and its equivalence to a predicate device, based on non-clinical performance testing. It does not describe a study involving an AI/Machine Learning driven medical device, human readers, or the establishment of ground truth by expert consensus for medical image interpretation or similar.

Therefore, most of the requested information regarding AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested for a physical device:

Acceptance Criteria and Device Performance for Blue Nitrile Examination Gloves Powder Free

This document describes the non-clinical performance of the "Blue Nitrile Examination Gloves Powder Free" and its substantial equivalence to a predicate device (K192333). The study performed is a series of laboratory tests to ensure the physical and chemical properties of the gloves meet established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample sizes for each test. However, it indicates compliance with ASTM standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process. The manufacturing location is Thailand ("Hi-Care Thai Gloves Co. Ltd. Thailand."). The specific tests are non-clinical, laboratory-based physical and chemical tests, not involving patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is for a physical device (examination gloves), not an AI/ML medical image analysis device requiring expert radiological review and ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. This is for a physical device, not an AI/ML medical image analysis device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is for a physical device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is for a physical device.

7. Type of Ground Truth Used:

For this physical device, the "ground truth" is defined by the physical and chemical properties of the gloves as measured against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D6319-10 for dimensions, physical properties, thickness; ASTM D5151-06 for water tightness/holes; ASTM D6124-06 for residual powder; ISO 10993 series for biocompatibility; USP for pyrogenicity and bacterial endotoxin).

8. Sample Size for the Training Set:

Not applicable. This is a manufactured physical good, not an AI/ML model.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

The provided text describes the 510(k) summary for the "Latex Examination Powder Free Gloves" device (K202377). This document focuses on demonstrating substantial equivalence to a predicate device (K192329) based on non-clinical performance data, as it is a Class I medical device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment with experts, or similar clinical evaluation methods are not applicable here.

The "device" in this context is a pair of medical examination gloves, not an AI/software device. The "study" refers to non-clinical tests performed to demonstrate the physical and chemical properties of the gloves meet established standards.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves (K202377)

The acceptance criteria for this device are established by adherence to recognized ASTM standards for rubber examination gloves. The study proving the device meets these criteria involves laboratory testing of various physical and chemical properties of the gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not explicitly state the numerical sample sizes for each test (e.g., how many gloves were tested for length, how many for tensile strength). However, it implies that samples were taken from different sizes (X-Small, Small, Medium, Large) to cover the range of the product.
• Data Provenance: The device manufacturer, Hi-Care Thai Gloves Co. Ltd., is listed with an address in Songkhla, Thailand. Therefore, the data originates from tests conducted on devices manufactured in Thailand. The testing is prospective in the sense that it's performed on the specific new device being submitted for clearance to demonstrate it meets pre-defined standards.

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

• This question is not applicable to this type of medical device submission. The "ground truth" for medical gloves is not established by expert clinical consensus or medical judgment, but by objective, standardized laboratory tests according to ASTM and ISO specifications. The qualifications of the personnel performing these tests would be in laboratory science, quality assurance, and adherence to test protocols, not necessarily medical expertise or experience.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, particularly for AI/reader performance evaluations, where there might be subjective interpretations or discrepancies among human readers. For physical and chemical tests of medical gloves, the results are quantitative and objective, directly compared against a numerical standard.

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 is not applicable. This submission is for a Class I physical medical device (gloves), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement metric, or AI assistance is relevant.

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

• This is not applicable. Again, this is for a physical medical device, not an algorithm or AI. The "performance" is the glove's ability to meet predefined physical and chemical properties.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device is based on established industry standards and regulatory requirements for physical and chemical properties as defined by the referenced ASTM and ISO standards. This is an objective, quantitative ground truth, as opposed to subjective clinical interpretations. For example, for "Length," the ground truth is "Min 230 mm," not an expert's opinion.

8. The Sample Size for the Training Set:

• This is not applicable. This is a physical product, not a machine learning model, so there is no "training set."

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

• This is not applicable as there is no training set for this device.

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