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  3. FEMALE CONDOM, lubricated, 170 mm, s.u.
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FEMALE CONDOM, lubricated, 170 mm, s.u.

https://unicat.msf.org/cat/product/19008
STD SMSUCONDF1-

Valid Article

Former Code(s): -X
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.
U110203 - Female 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
CT3+
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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FEMALE CONDOM

Definition

Cylindrical, soft, thin, transparent sheath, lubricated, with flexible ring at each end.

The smaller inner ring, at the closed end, helps with insertion and secures the condom during intercourse.

The larger outer ring remains outside the vagina to anchor the condom so that the sheath covers the vulva as well as the base of the penis during intercourse.

Used for protection against sexually transmitted infections and for contraception.

Specifications

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Quality standards

  • WHO/UNFPA, 2012, female condom generic specification. Prequalification and guidelines for procurement
  • ISO 25841, 2017, edition 3, Female condoms - Requirements and test methods

Technical specifications

Meets the WHO specifications:

  • Sheath and outer ring made of nitrile
  • Inner ring made of polyurethane
  • Silicone-based lubricant
  • Shape: cylindrical
  • Smooth texture
  • Colourless, odourless, transparent
  • Non-irritating
  • Length: 163-183 mm
  • Width: 76-83 mm at its widest diameter
  • Thickness: 65-85 µ
  • Tensile strength: minimum 10.3 MPa
  • Burst strength: minimum 3.2 litres
  • Water leakage: no visible hole
  • Non sterile, for single use

Packaging & Labelling

Individually packed in a sealed plastic envelope

Instructions for use

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Precautions for Use

Never use a condom if the individual package is damaged or defective.

Storage

Store between 2° and 40º C, Protect from sunlight ‐ Protect from humidity

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