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This document provides a summary of a 510(k) premarket notification for the Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV, detailing its intended use, technological characteristics,
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How to fill out 510k summary - emm
How to fill out 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV
01
Review the FDA's guidelines for submitting a 510(k) summary.
02
Gather all necessary documentation, including product specifications and testing results.
03
Prepare a description of the EMM Surgical Gown and its intended use.
04
Include information on the MAMI Liquid Barrier Level IV properties and performance testing.
05
Demonstrate substantial equivalence to a pre-existing device by providing comparison data.
06
Compile labeling information such as instructions for use, warnings, and contraindications.
07
Ensure that all information is clear and concise, following the FDA's formatting requirements.
08
Submit the completed 510(k) summary along with any applicable fees to the FDA.
Who needs 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
01
Manufacturers of EMM Surgical Gown looking to market their product in the U.S.
02
Healthcare facilities and providers wanting to ensure compliance and safety for usage.
03
Regulatory affairs professionals assisting manufacturers with compliance.
04
Investors evaluating the marketability of the surgical gown.
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People Also Ask about
What is an IV gown?
Packard Healthcare Isolation Gowns offer AAMI Level 2 protection providing water resistance ideal for use in procedures with a low risk of exposure. These disposable, blue SMMS isolation gowns are available with a knit cuff or an Elastic Cuff with Thumb Loop and feature a full back with a tie. AAMI Level 2.
What is a Level 4 surgical gown?
These Level 4 gowns keep fluids away from the caregiver and protect against the transfer of microorganisms, particulates, etc from or to the caregiver in a clinical space. COMPLIES WITH AAMI PB 70 STANDARD (SURGICAL DRAPES & GOWNS) MEETS AAMI LEVEL IV FOR SYNTHETIC BLOOD AND VIRAL .
What is a Level 2 surgical gown?
Levels of Medical Gowns Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit. Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab.
What is a Level 2 surgical gown?
Packard Healthcare Isolation Gowns offer AAMI Level 2 protection providing water resistance ideal for use in procedures with a low risk of exposure. These disposable, blue SMMS isolation gowns are available with a knit cuff or an Elastic Cuff with Thumb Loop and feature a full back with a tie. AAMI Level 2.
What is the difference between Level 3 and Level 4 surgical gowns?
Our IV Patient Gowns are designed with your medical facility in mind. With hospital gowns with snaps and telemetry pockets included on all models, patients can feel comfortable and secure during their stay.
What barrier level gown for high risk exposure?
Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
What are Level 3 surgical gowns?
When tested, AAMI Level 3 surgical gowns demonstrate the ability to resist moderate fluid exposure while AAMI Level 4 surgical gowns demonstrate the ability to resist high fluid exposure and blood borne pathogens.
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What is 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
The 510(k) Summary for the EMM Surgical Gown with MAMI Liquid Barrier Level IV is a document submitted to the FDA to demonstrate that the medical device is safe and effective and is substantially equivalent to an already approved device.
Who is required to file 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
Manufacturers of the EMM Surgical Gown with MAMI Liquid Barrier Level IV must file a 510(k) Summary to obtain premarket clearance from the FDA before marketing the device in the United States.
How to fill out 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
Filling out a 510(k) Summary involves providing information about the device, including its intended use, technological characteristics, labeling, and performance data, along with a comparison to a predicate device.
What is the purpose of 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the EMM Surgical Gown with MAMI Liquid Barrier Level IV is safe and effective for its intended use and whether it is substantially equivalent to existing devices.
What information must be reported on 510(k) Summary - EMM Surgical Gown with MAMI Liquid Barrier Level IV?
The 510(k) Summary must include information such as the device description, indications for use, technological characteristics, a comparison to predicate devices, performance testing results, and manufacturing details.
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