Get the K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove - accessdata fda
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This document details the submission and summary of a 510(k) premarket notification for the AmerCare C2 Powder Free Polyethylene Examination Glove, outlining its characteristics, intended use, and
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How to fill out k113639 - amercare c2
How to fill out K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove
01
Gather all necessary materials, including the K113639 AmerCare C2 Powder Free Polyethylene Examination Gloves.
02
Ensure your hands are clean and dry before handling the gloves.
03
Open the glove box carefully to avoid damaging any gloves inside.
04
Take one glove out of the box by gripping the glove from the wrist area to maintain cleanliness.
05
Insert your dominant hand into the glove, pulling it on until it fits comfortably.
06
Repeat the process for your other hand using the second glove.
07
Adjust both gloves to ensure a snug fit, checking for any tears or defects.
08
Dispose of any damaged gloves properly and wash your hands before and after use.
Who needs K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
01
Healthcare professionals conducting medical examinations or procedures.
02
Laboratory technicians handling samples or chemicals.
03
Food service workers who need to maintain hygiene while handling food.
04
Home care aides providing assistance to patients or clients.
05
Individuals or organizations requiring disposable gloves for sanitation and safety purposes.
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People Also Ask about
What are examination gloves used for?
Medical gloves are examples of personal protective equipment used to protect the wearer and/or the patient from the spread of micro-organisms that may potentially cause infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy.
What are nitrile powder free gloves used for?
Nitrile gloves As such, these gloves are the ideal choice for anyone who has to handle potentially hazardous and corrosive chemicals. They are also perfectly suited for most medical environments, being exceptionally puncture-resistant and eliminating the risk of latex allergy reactions.
What are polyethylene gloves used for?
Plastic Disposable Gloves are most commonly referred to Polyethylene gloves, or also known as PE gloves. These types of disposable gloves are most commonly used in the food industry or beauty industry (for dying hair).
What are latex exam gloves used for?
Latex is one of the most commonly used gloves in the healthcare industry due to their varied features: comfortable, cost-effective, and provide ample protection. Healthcare professionals use these gloves during medical examinations to safeguard themselves from harmful substances.
Are powder free gloves really powder free?
During the manufacturing of powder free latex gloves, gloves are rinsed both inside and out to remove any powder residue left over from the manufacturing process. In some manufacturing processes, chlorination is then used to remove any residual powder particles from the gloves.
What can latex gloves be used for?
Latex gloves offer a high degree of protection against a broad range of hazards, including chemical and biohazards, and abrasive or tearing hazards. Latex provides a greater level of strength and protection against punctures and tears than vinyl gloves.
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What is K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove is a type of personal protective equipment designed for use in medical and healthcare settings. These gloves are made from polyethylene material and are latex-free, making them suitable for individuals with latex allergies.
Who is required to file K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
Manufacturers or importers of the AmerCare C2 Powder Free Polyethylene Examination Gloves are required to file K113639 to ensure compliance with safety and regulatory standards set by health authorities.
How to fill out K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
To fill out K113639 for the AmerCare C2 Powder Free Polyethylene Examination Glove, the manufacturer or responsible party must provide detailed information including product identification, intended use, manufacturing details, and labeling information in the designated sections of the application form.
What is the purpose of K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
The purpose of K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove is to ensure that the product meets regulatory safety standards and is safe for use in examination and healthcare procedures, protecting both patients and healthcare providers.
What information must be reported on K113639 - AmerCare C2 Powder Free Polyethylene Examination Glove?
The information that must be reported on K113639 includes the product name, active ingredients, indicated uses, manufacturing specifications, testing results for safety and efficacy, labeling information, and any adverse effects associated with the use of the gloves.
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