Good morning everyone!
I came across a specific medical device product that is described as a "Barrier Cream"
Some indications that come with it are the following:
• Suitable for wet areas
• It helps maintain the pH of the skin and skin moisture.
This product is applied to intact and at-risk skin to provide protection from body fluids and moisture. It can be applied around wounds, wound dressings and incontinence pads where a protective barrier will help prevent skin breakdown.
Could someone help me to classify this medical device? From my point of view, it is a (Rule 4) Class I MD. But I have had a discussion with a friend that thinks it's Class II. Any feedback would be helpful.
I came across a specific medical device product that is described as a "Barrier Cream"
Some indications that come with it are the following:
• Suitable for wet areas
• It helps maintain the pH of the skin and skin moisture.
This product is applied to intact and at-risk skin to provide protection from body fluids and moisture. It can be applied around wounds, wound dressings and incontinence pads where a protective barrier will help prevent skin breakdown.
Could someone help me to classify this medical device? From my point of view, it is a (Rule 4) Class I MD. But I have had a discussion with a friend that thinks it's Class II. Any feedback would be helpful.