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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:

Finger
X-Small: 0.13mm
Small: 0.13mm
Medium: 0.14mm
Large: 0.13mm
X-Large: 0.14mm |
| ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 1.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Residual Powder Content
X-Small: 0.21mg/glove
Small: 0.21mg/glove
Medium: 0.22 mg/glove
Large: 0.22 mg/glove
X-Large: 0.22 mg/glove |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Minimal for all sizes
After Ageing: Tensile Strength 14Mpa Minimal for all sizes | Tensile Strength (Mpa)
Before Ageing
X-Small: 18.43
Small: 18.49
Medium: 18.54
Large: 18.57
X-Large: 18.64

After Ageing
X-Small: 17.49
Small: 17.51
Medium: 17.65
Large: 17.67
X-Large: 17.71 |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes
After Ageing: Ultimate Elongation 400% Min for all sizes | Ultimate Elongation (%)
Before Ageing
X-Small: 685
Small: 688
Medium: 692
Large: 695
X-Large: 698

After Ageing
X-Small: 654
Small: 658
Medium: 661
Large: 665
X-Large: 669 |
| Biocompatibility (Primary Skin Irritation - ISO 10993-10:2010(E)) | Biocompatibility | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Biocompatibility (Dermal Sensitization - ISO 10993-10:2010(E)) | Biocompatibility | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| Biocompatibility (In vitro cytotoxicity - ISO10993-5:2009(E)) | Biocompatibility | (Predicate: Under the conditions of the study, cytotoxic) (Subject: Under the conditions of the study, non-cytotoxic) | Under the conditions of the study, non-cytotoxic |
| Biocompatibility (Acute Systemic Toxicity Test ISO 10993-11:2017(E)) | Biocompatibility | Under the condition of study not systemic toxic | Under the conditions of study, the device extracts do not pose a systemic toxicity concern |
| Biocompatibility (Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41) | Biocompatibility | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| Biocompatibility (Bacterial Endotoxin test USP 42) | Biocompatibility | (Predicate: No data available) (Subject:

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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:

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