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

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


;)

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 ?

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?

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

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

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

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).

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).

:topic: So how does this stuff work if it creates a protective barrier, is "super-glue" yet does not come into contact with the cut? (forgive me, I have been in emergency medical services way too long, this stuff always piques my interest.) It sounds like you are covering bandaging material with your barrier/glue substance? To what purpose? I am just confused as to the use. Sorry, I cannot answer your question, it is out of my area of expertise (that term is used very loosely:lmao: )

Sounds like liquid skin, super glue with a different name.
Is that correct ? applied directly to the cut ?
Ed

If it's not applied directly to the wound I would surmise that it is used in conjunction with some type of bandage...my guess is that it is used for covering the bandage to act as a barrier and adhesive? I am also curious, clarification would be good. ;)

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).

:topic: So how does this stuff work if it creates a protective barrier, is "super-glue" yet does not come into contact with the cut? (forgive me, I have been in emergency medical services way too long, this stuff always piques my interest.) It sounds like you are covering bandaging material with your barrier/glue substance? To what purpose? I am just confused as to the use. Sorry, I cannot answer your question, it is out of my area of expertise (that term is used very loosely:lmao: )

While I don't have an answer either, he says that it will come in contact with the cut.

guess I can't read....makes me feel pretty stupid:bonk: thanks for the catch.

From what you said rule 4 should be applicable.
In this case, if you can prove that your products is "intended to be used as a mechanical barrier,
for compression or for absorption of exudates" class I should be OK.

OK, so now you see why I am struggling with classification.
Here is the intended use, you have a papercut and playing guitar, use liquid bandage, no more pain, play away.....or you are playing sport, have a nick or cut, use liquid bandage. :bonk:

OK, so now you see why I am struggling with classification.
Here is the intended use, you have a papercut and playing guitar, use liquid bandage, no more pain, play away.....or you are playing sport, have a nick or cut, use liquid bandage. :bonk:

I know of one product, trade name is "Sofra Tulle" which contained Framycetin sulphate (antibiotic) impregnated on a bandage gauze. This is an excellant product, where it is placed directly on the burns and wounds etc.

This tulle was not classified as a device but is a drug

Sounds much like the Compeed Liquid Bandage sold by J&J in UK.

I suggest getting one and checking their labelling. If it is class 1 non-sterile, it should have a plain CE Mark without a number. If it is sterile or class 2a or higher, it will have a number after the CE Mark.

Thank you everyone.

:thanx: