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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.

The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.

The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.

The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.

The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.

The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.

The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.

The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.

The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".

1. Table of Acceptance Criteria and Reported Device Performance

The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.

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The Powder-Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with Protein Labeling Claim (50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s) to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

Acceptance Criteria and Device Performance Study for Powder Free Latex Examination Gloves

This report details the acceptance criteria and the study that proves the performance of the "Powder Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less)" by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (K042645).

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and FDA regulations. The following table summarizes the acceptance criteria and the reported performance of the device:

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The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s)to prevent contamination between patient and examiner.

Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Nitrile Examination Gloves (Blue) with Natural Water Soluble Vitamin E and Aloe Vera, Peppermint Scented."

It's important to note that this device is a Class I medical device (patient examination glove), which typically undergoes different and less stringent testing than more complex AI-powered diagnostic devices. Therefore, many of the requested categories (like MRMC studies, expert consensus on ground truth, or sample sizes for test/training sets in the context of an AI algorithm) are not applicable here.

Acceptance Criteria and Device Performance

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The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for "POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS PER GRAM OF GLOVE)".

It's important to note that this is a medical device submission for examination gloves, not an AI/Software as a Medical Device (SaMD) submission. Therefore, many of the typical questions related to AI studies (like MRMC, training set details, expert qualifications for AI ground truth) are not applicable to this type of device. The focus here is on physical and chemical performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.

This is an examination glove, not an AI/ML device. Hence, the requested information about AI/ML device studies and ground truth is not applicable.

However, I can provide the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance

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Ask a specific question about this device