B2B product sheet

PAMITEX XL

PLPXLK · PAMITEX

PAMITEX XL is the larger-size option of the professional range, for the selected markets and channels where size drives the demand. Each condom is made from natural rubber latex, natural in colour, with a smooth surface, a lubricated finish and a reservoir end, and is electronically tested, unit by unit. A single-use CE 0123 Class IIb medical device under EU Regulation 2017/745, presented in the professional box of 144, at a nominal 60 mm width and 210 mm length.

BrandPAMITEX
Product codePLPXLK
CategoryCondoms
FormatXL size, box of 144
PackagingBox of 144 condoms
MaterialNatural rubber latex (NRL)
SurfaceSmooth
LubricationLubricated
ReservoirYes
Nominal width60 mm
Length210 mm
StandardEN ISO 4074
EAN8852961021707

Compliance

RegulationRegulation (EU) 2017/745, Annex IX, Chapters I and III
Device classClass IIb
Device groupU110101 (Condoms)
Notified BodyEU Notified Body

Important information

This product is made of natural rubber latex, which may cause allergic reactions including anaphylactic shock in people who are allergic to latex. It must not be used by people with a latex allergy. Consult a doctor or a pharmacist about the risk of an allergic reaction before use, and seek medical advice if a reaction occurs.

This sheet is for qualified B2B evaluation and does not constitute medical, legal or regulatory advice.

B2B contact: info@pamitex.com · WhatsApp +36 70 755 1700