Knowledge base

CE conformity marking

Conformity marking for PPE for medium risk (category II)

CE conformity marking with the notified body number and address for cat. III PPE

CE conformity marking with the notified body number and address for cat. III PPE

Conformity marking with the notified body number for surgical gloves

Date of manufacture

Designation of an authorised European representative of the product manufacturer; indicate name and address

EN 1149-1 Gloves with anti-static properties

EN 374-1 chemical protection gloves;
accompanied by a 3-digit code referring to three
chemical substances in the list No. 12 as defined in Annex A to EN 374-1, for which the breakthrough time is at least 30 minutes

EN 374-1 water resistant gloves;
the graphic symbol used if the gloves have been tested for resistance to chemical substances, but were not resistant to 3 indicated in Annex A to EN 374-1 at least at level 2 (30 minutes) or were tested for other substances

En 374-2-Gloves resistant to microorganisms;
gloves with AQL of ≤1.5

EN 388 - gloves for protection against mechanical hazards, where the letters indicate
a - abrasion resistance
b - blade cut resistance
c - tear resistance
d - puncture resistance
instead of letters, levels of abrasion, blade cut, tear, puncture resistance are provided, e.g. 1 0 1 0

Food Contact Material - does not alter characteristics of food.

see the instructions for use

Gloves made of natural rubber latex - may cause allergic reactions, including anaphylactic reactions

Lot No./Batch No. assigned by the manufacturer

Manufacturer – provide name and address of the manufacturer

Neoprene gloves - company’s own pictogram

Nitrile gloves - company’s own pictogram

No phthalates - company’s own marking placed on vinyl gloves

Non-sterile

Polyisoprene gloves - company’s own pictogram

Powder-free gloves– company’s own pictogram

Powder-free gloves with a polymer layer inside – company’s own pictogram

Powder-free gloves with a skin-care layer – company’s own pictogram

Gloves powdered with corn starch/flour – company’s own pictogram

Product approval mark for sale in Ukraine

Product expiry date

Product quality/sterility not guaranteed if packaging is opened or damaged

Storage conditions - protect from moisture

Storage conditions - protect from ozone

Storage conditions - protect from sunlight and fluorescent light

Sterile, sterilised with ethylene oxide.

Sterile, Gamma sterilised/irradiated

Single-use product (for one patient and one procedure)

Storage conditions - store in the indicated temperature ranges ( 5-35°C)

Gloves with textured surface - company’s own pictogram

Vinyl gloves - company’s own pictogram

Do not re-sterilise the product