Product type – medical device + personal protective equipment
Medical device class – I (Regulation (EU) 2017/745)
PPE category – III (Regulation (EU) 2016/425), notified body 2777
Brand – MERCATOR (comfort® powder-free)
Material – natural rubber latex
Colour – cream
Sterility – non-sterile
Inner surface – powder-free
Shape – ambidextrous
Cuff – beaded
Standards – EN 455-1, -2, -3, -4; EN ISO 374-1:2016+A1:2018 (Type B: K, P, T); EN ISO 374-2:2019; EN ISO 374-4:2019; EN ISO 374-5:2016 (VIRUS); EN ISO 21420:2020; EN 16523-1:2015+A1:2018
Food contact – suitable (marked with the food contact symbol)
Quantity – 100 pcs per box (by weight)
Shelf life – 3 or 5 years (depending on LOT number)
Storage – in a dry place at 5–35 °C, protected from sunlight
Warning – contains natural rubber latex which may cause allergic reactions, including anaphylactic responses
Manufacturer – Mercator Medical S.A., Poland

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