Are Polyethylene-folie gloves considered Medical Device ?

S

Sztpyol

#1
Hello everyone,

My problem is that I can not find a CE mark ont he packaging of the Polyethylenfolie gloves. I think the PE gloves are medical devices.

[FONT=&quot]Thank you for your help[/FONT]
 
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M

MIREGMGR

#2
Re: Polyethylenfolie Gloves - Medical Device or Not

Polyethylene film gloves often are used in food handling, but not usually in medical care...at least, not in my experience. Medical device gloves usually are nitrile (i.e. synthetic rubber), vinyl, or the traditional natural rubber latex.

Perhaps the maker of the gloves didn't CE Mark them under MDD because they weren't envisaged as a medical device.

Did the seller from whom you bought them market them as a medical device?
 

pkost

Trusted Information Resource
#3
Re: Polyethylenfolie Gloves - Medical Device or Not

In addition to MIREGMGR's post, in the EU you may also want to consider the PPE directive

Depending on the claims made:
Gloves that protect the patient from bacteria/microbes on the wearer's hands = medical devices
Gloves that protect the wearer from the patient's bacteria/microbes = PPE

Gloves that claim to do both must comply with both directives
 
S

Sztpyol

#4
Hello,

and thanks for the answers. The problem is that I have to make a decision about it in a purchasing project. Can I ask the suppliers/producers to show the CE mark on the packaging and the declaration of conformity according to 93/42MDD? In case of the PE gloves are medical devices according to 93/42MDD I can. That is the reason I would like to know what are the "status" of the PE gloves.

Thank you very much in advance.

Best regards
 
M

MIREGMGR

#5
As a purchaser within EU: if a polyethylene film glove does not have the CE Mark on its packaging, it must not be a medical device.

The fact that you perceive them to be suitable for a medical device task is irrelevant. If the legal manufacturer does not CE Mark them as a medical device, they are not a medical device.
 
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