WHO/UNFPA Prequalified Female Condoms

 

The WHO/UNFPA prequalification mechanism integrates the UNFPA Female Condom Prequalification Scheme and the WHO/RHR Technical Review Process. A prequalified female condom will have had its manufacturing site inspected and will have successfully undergone independent testing of the product. UNFPA ensures that the manufacturer meets the minimum requirements detailed in the relevant ISO standards, including ISO 25841: 2011 and the detailed prequalification procedures outlined in the WHO/UNFPA Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012.

UNFPA maintains a list of prequalified female condom manufacturers and sites that have successfully completed the WHO/UNFPA prequalification process and have been approved by the WHO/RHR Technical Review Committee.

For more details on the UNFPA/WHO prequalification mechanism click here.

Below FCMi provides an overview of currently prequalified female condoms (listed in alphabetical order). Please click on the manufacturer to go to the relevant FCMi company profile.

Female Condom

Design & Features

Regulatory Status and Availability

Useful Product Links


Female Condom

Cupid®

Cupid Ltd. India

Cupid1

WHO/UNFPA Prequalified Manufacturing Site

Cupid Ltd.
A - 68, M.I.D.C.
Malegaon
Sinnar
Nashik - 422 113
India

Design & Features

  • Also branded as l’Amour® and Jeitosa®.
  • Made of natural rubber latex.
  • Has an octagonal outer frame and is inserted using a medical-grade sponge which also holds the condom in place during use.
  • Pre-lubricated with silicone oil.
  • Comes in transparent or pink color.
  • Is the only scented female condom

Regulatory Status and Availability

  • CE marking
  • WHO/UNFPA prequalified in 2012  (requalified in 2015)
  • USFDA registration process initiated in 2012

Distributed in 18 countries

 

Useful Product Links

Specification for the Cupid® prepared by the manufacturer

Document provides information on:

  • the product design
  • the material used
  • contact info

Cupid Company website


Female Condom

FC2®

The Female Health Company

FC2

WHO/UNFPA Prequalified Manufacturing Site

The Female Health Company (M) SDN BHD
No. 1A, Jalan CJ 1/4,
Kawasan Perindustrian Cheras Jaya
43200 Balakong. Selangor
Malaysia

Design & Features

  • Also branded as Femidom®, Protectiv, Care and many other names.
  • Made of nitrile (synthetic latex).
  • Flexible circular inner ring to insert the device and keep it in place during use, and a flexible circular outer ring to protect the genital area.

Regulatory Status and Availability

  • CE marking
  • WHO/UNFPA prequalified in 2007 (requalified in 2012 and 2015)
  • USFDA approved in 2009
  • SABS accredited
  • Available in 143 countriesAvailable in 143 countries

Useful Product Links

FC2® female condom 

Website dedicated to the FC2® female condom including information on:

  • usage
  • where to find the FC2®

Training website: www.femalecondom.org/materials

 


Female Condom

Velvet

HLL Lifecare Ltd

HLL Female Condom

Design & Features

  • Made of natural rubber latex.
  • Has an outer flexible circular ring and is inserted with an inner flexible circular copolymer ring, to aid retention during sexual intercourse.

Product Status

  • CE Mark
  • SABS Mark
  • WHO/UNFPA prequalified (March 2016)
  • Registered in India and available in the retail market.
  • Product registration done in Ecuador, currently underway in Brazil.
  • Distributed to: Australia, Bahamas, Brazil, India, Nepal (HLFPPT presentation)

Useful Links

HLL Lifecare Limited presentation on the HLL Female Condom and the VA w.o.w.® female condom given at the International Platform for Female Condoms Strategic Meeting, Addis Ababa, Ethiopia, November 2013.


Female Condom

Woman's Condom

Dahua Medical Apparatus Company

Woman's Condom

Design & Features

  • Also known as O’lavieTM in China.
  • Made of polyurethane.
  • Has a tampon-like insertion capsule which dissolves after insertion. Four little foam dots on the outside of the condom ensure internal stability.
  • A flexible circular ring ensures outer retention.
  • Not pre-lubricated: separate water-based lubricant is supplied in a sachet.

Product Status

  • CE marking
  • South Africa Bureau of Standards (SABS) certification mark
  • Shanghai Food and Drug Administration approval
  • Currently undergoing contraceptive effectiveness study needed for USFDA approval
  • Registered in China (O'Lavie), South-Africa (V female condom), Malawi (Whisper) and Zambia (Maximum Diva)
  • WHO/UNFPA prequalified (March 2016)

 

Useful Product Links



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