Non-sterile liquid bandage as Class 1 - Anyone concur or disagree?

[Achemd]

I have gone thru all the documentation as would like some assurance that I can read correctly

I classify a non-sterile liquid bandage as class 1, anyone concur or disagree?

THanks

[gereard_kgb]

I think more data on the product and intended use would be welcome to give reasonable comments...

[Ajit Basrur]

Originally Posted by Achemd

I have gone thru all the documentation as would like some assurance that I can read correctly

I classify a non-sterile liquid bandage as class 1, anyone concur or disagree?

THanks

Which markets are you targetting ?

[Aaron Lupo]

Originally Posted by Achemd

I have gone thru all the documentation as would like some assurance that I can read correctly

I classify a non-sterile liquid bandage as class 1, anyone concur or disagree?

THanks

Dermabond, which is a sterile tissue adhesive for soft tissue approximation, is a class 3 device. Any similarities to your device?

[Achemd]

Dermabond is a wound closure tissue adhesive and is sterile. We are trying to market a liquid bandage, non-sterile and as a protection.

[gereard_kgb]

How about the intended use - is to going to get in touch with a wound?

[Benjamin28]

In my days in a maintenance shop we called this kind of bandage "super glue" worked fantastic for those (superficial) cuts.

[Achemd]

exactly what it is, super glue.
Intended use is protective barrier, but does come into contact with the cut. Again is non-sterile and NOT a wound closure like Dermabond (we have a class IIa with approved CE Mark).