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CONDOM, lubricated + RESERVOIR, s.u.

https://unicat.msf.org/cat/product/19009
STD SMSUCOND1--

Valid Article

Former Code(s): -X SMSUZFR0053
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
22.1.4 - Barrier methods
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
U110101 - Condoms
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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MALE CONDOM

Definition

Cylindrical, soft, thin, elastic sheath ending in a reservoir, which fits over the penis.

Used for protection against sexually transmitted infections and for contraception.

Synonym

Durex, French letter, rubber Johnny, sheath, Wellington boot, rubber, raincoat...

Specifications

WHO/UNFPA Technical Specifications for male latex condoms (July 2020)

Quality standards

ISO 4074, 2015, edition 3, Natural latex rubber condoms - Requirements and test methods

Technical specifications

  • Natural latex
  • Lubricant made of silicone, PEG/N9 etc. with or without starch powder (the manufacturer must specify the level of lubrication)
  • With reservoir
  • Integral rolled rim
  • Smooth texture
  • Odourless
  • Length: > 160 mm
  • Width: 49 - 53 mm, +/- 2 mm
  • Rupture resistant:
    • Burst pressure > 1 kPa
    • Burst volume > 18 dm³ (with a condom > 50 mm and < 56 mm)
    • Test made before and after oven-treatment
  • Tested for shelf-life and stability
  • Non sterile, for single use

Packaging & Labelling

  • Unit packaging, opaque, strong, easy to open without damaging the condom.
  • Individual package size: 50.8 x 50.8 mm to 57.15 x 57.15 mm
  • Inner boxes contain a moisture resistant barrier
  • The exterior shipping carton is made from weather resistant corrugated fibreboard
  • Minimum labelling requirements: manufacturer's name, batch number (for tracing) and expiry date.

Instructions for use

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Precautions for Use

  • Never use a condom if the individual package is damaged or defective
  • Never use petroleum- or oil-based lubricants (Vaseline, cooking oil, fat, lotion...) since these may damage the latex
  • Use only water-based lubricants
  • A lubricant (water-based) should always be used for anal penetration

Storage

Store below 30°C, Protect from sunlight ‐ Protect from humidity

Avoid glove compartment, trouser pocket or container left in direct sunlight!

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