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The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim

The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim."

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1. Table of Acceptance Criteria and Reported Device Performance

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Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. A 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 the patient and the examiner.
Summary of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL

This document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue" (K112012), not an AI device. Therefore, many of the requested sections related to AI device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.

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1. Table of Acceptance Criteria and Reported Device Performance

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The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger)
Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end)
BEFORE AGING Tensile Strength: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL

The provided document describes the acceptance criteria and performance of a Powder-Free Black Latex Examination Glove. It does not describe a study involving an AI-powered device or human readers. Therefore, several requested sections, such as those pertaining to AI model performance, human expert involvement, and training/test set details, are not applicable.

Here's the available information presented in the requested format:

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

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