nitrile exam glove fda disposable face

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nitrile exam glove fda disposable face

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

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FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

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Exam Gloves | McMaster-Carr

Static-control gloves minimize the buildup of electrostatic charge to protect sensitive equipment from damage. They have antistatic properties. Nitrile gloves are a good alternative for those concerned with latex allergies. Neoprene gloves are durable and resist tears, chemical spills, and splashes better than any other disposable glove we offer.

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US FDA 510k and Registration for Gloves

Sep 21, 2020·A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. OIG . Device Name

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Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.