Procondom is the result of 20 years of experience in the condom and lubricant market. Imagined by its founder Wilfried Borg , to facilitate the supply and sourcing of condoms and lubricants, for specialized resellers, associations and public establishments.

At Procondom we have been selling condoms since 2003, and we created the Condomz brand, which is now widely distributed.

With Procondom you will have the guarantee of purchasing quality products, respecting current standards and stored in appropriate conditions.

All our products are stored in our premises in France in Montauban, Tarn et Garonne (82) with our logistics and sales teams. Procondom is a platform created by the company MB Lab.

The condoms distributed by the company MB LAB, on Procondom all bear the CE marking (with an identification number) of compliance with the European Directive on medical devices.

International Certifications : Condoms are manufactured in factories certified to the highest international standards, such as ISO 4074 for latex condoms.

Rigorous Testing : Each batch of condoms undergoes rigorous testing to ensure their reliability and safety, such as puncture, elasticity and durability tests.

Regular Audits : regular audits of production facilities to ensure that quality standards are consistently met.

Le MDR, ou Règlement (UE) 2017/745 relatif aux dispositifs médicaux, est entré en application en mai 2021. Il remplace l’ancienne directive MDD (93/42/CEE) et a profondément réformé la réglementation des dispositifs médicaux en Europe.

Les préservatifs étant des dispositifs médicaux, ils dépendent donc du MDR.

Objectifs du MDR

Renforcer la sécurité des patients

Améliorer la traçabilité des dispositifs

Rendre les fabricants plus responsables

Renforcer les exigences cliniques et techniques

Ce que le MDR change concrètement

1. Reclassification des dispositifs
   Certains produits ont changé de classe (ex : lubrifiants passant de classe I à classe IIa selon leur usage), ce qui implique des obligations plus strictes.
2. Évaluation clinique renforcée
   Des preuves cliniques solides sont désormais requises, même pour des produits similaires déjà sur le marché.
3. Surveillance post-commercialisation: Les fabricants doivent mettre en place des systèmes robustes pour suivre la sécurité et les performances de leurs produits une fois vendus.
4. UDI et traçabilité
   Introduction d’un identifiant unique (UDI) sur les dispositifs pour améliorer la transparence et le suivi.
5. Dossier technique plus exigeant : Le contenu du dossier réglementaire doit être plus complet, notamment sur la composition, la fabrication, les risques, la biocompatibilité, etc.
   
   Impact pour les fabricants

Le MDR implique :

• Des coûts réglementaires plus élevés
• Des délais de mise sur le marché plus longs
• Une collaboration plus étroite avec les organismes notifiés
• Un investissement important en qualité, documentation et clinique.

Exemple : les lubrifiants

Un lubrifiant peut être un DM de classe I ou IIa selon sa finalité (simple confort ou usage médical).

Sous MDR, un lubrifiant médical : - doit prouver sécurité et son efficacité clinique.

- avoir marquage CE basé sur des données concrètes

Pourquoi c’est une bonne chose

Malgré la complexité, le MDR est bénéfique pour :

- confiance des utilisateurs (patients comme professionnels)
- meilleure transparence du marché
-réduction des risques liés aux dispositifs défectueux ou peu évalués

Traçabilité et conformité : Procondom vous accompagne

Dans le cadre de votre activité avec Procondom, nous vous transmettons :

- certificats de conformité MDR
- informations de traçabilité produit
- fiches techniques et documents de qualité nécessaires à votre propre conformité réglementaire

Notre engagement : vous fournir des produits sûrs, traçables, conformes, avec un support complet pour vos besoins B2B.

Tout dépend de leur finalité déclarée et de leur réglementation.

Un lubrifiant peut être :

- Un dispositif médical (DM), lorsque le lubrifiant est destiné à un usage médical, comme faciliter les examens gynécologiques ou réduire la sécheresse vaginale en contexte pathologique.

produit cosmétique, lorsque le lubrifiant intime est destiné à améliorer le confort et le plaisir intime, sans revendication thérapeutique.

Lubrifiant DM vs Lubrifiant Cosmétique : quelles différences réglementaires ?

Lubrifiant intime classé Dispositif Médical (DM) :

- Usage médical, prévention ou traitement

- Procédure de mise sur le marché : Marquage CE obligatoire (procédure plus lourde)

- Controle qualité : Conforme au règlement DM (UE 2017/745)

- Etudes cliniques, souvent requises.

Le laboratoire en charge de la formulation s'occupe de tout.

Lubrifiant Cosmétique

- Usage : Bien être et confort

- Contrôle qualité : Conforme au règlement cosmétique (CE 1223/2009)

- Déclaration auprès de l'ANSM, une notification sur le portail du CPNP (Cosmetic Products Notification Portal) de la commission européenne. (Il faut indiquer le PR (Personne responsable) et établir un DIP (Dossier information produit) avec les informations suivantes :

- Formule Qualité/quantitative

- Rapport de sécurité

- Allégations marketing

- Données sur les effets indésirables

- Etiquetage conforme.

Le laboratoire en charge de la formulation s'occupe de tout.

Pourquoi de nombreuses marques privilégient le statut cosmétique ?

- Procédures réglementaires plus simples

- Moins de coûts de développement (pas d’études cliniques imposées), cela peut représenter plus de 60K€

- Plus de réactivité sur le marché

Cela permet aux marques d’offrir des lubrifiants sûrs, agréables et qualitatifs, tout en restant compétitifs.

Cosmétique ≠ produit au rabais

Un lubrifiant classé comme cosmétique reste soumis à un cadre réglementaire strict, notamment sur la sécurité et la tolérance cutanée.

Quand recommander un DM ?

Lorsque l’usage est lié à un besoin médical identifié : sécheresse sévère, examens cliniques, post-traitement.

Sinon, pour les usages courants, les lubrifiants cosmétiques sont parfaitement adaptés et bien tolérés.

The personalized pouches containing a condom are designed by a “packer” respecting the ISO 13485 standard, and having a contract authorizing him to work with the brand concerned, which engages his responsibility. This is the case with our partners when you ask us for these customization projects.

Condoms are medical devices, it is not possible to buy condoms removed from their original packaging, containing the standards and legal notices.

Modifying packaging is prohibited by distributors.

In addition, condoms cannot be sold without an information booklet and protective packaging. The only ones with an exemption are NGOs with very specific conditions.

The unit of sale is the cardboard box, not the foils inside the box.

Selling without protective packaging calls into question the protection of individual packaging (foil). A new risk analysis and a new transport study is necessary.

Under the DM regulations , a distributor who assumes the right to repackage, modify the information on the packaging, the packaging itself, must do so.

• either within the framework of a written contract with the manufacturer and each batch subject to modification must be released by the manufacturer,
• or the distributor must add his name to the packaging and take responsibility for modification, and be certified according to article 16.

Thus, a distributor who distributes condoms taken out of their original packaging is illegal.

It is however possible to buy condoms in bulk, in pouches, in boxes or bags, but in their original packaging.

It is possible to create your own brand of condoms, but this imposes many constraints and rules to respect, and the budget, it is in fact not possible to launch a creation project for small quantities, given the many inherent costs manufacturing, control and numerous administrative declarations to the competent authorities. However, we can support you on this project.

Création d'une marque de préservatifs en France : cadre réglementaire, industriel et marketing

Créer une marque de préservatifs en France est un projet structurable, à condition de respecter la réglementation applicable aux dispositifs médicaux de classe IIb. On vius présente ici les étapes clés du processus, les obligations réglementaires, ainsi que les coûts indicatifs associés.

Les équipes de Procondom peuvent vous aider dans votre réflexion, de la création de la marque, packaging, site marchand.

1. Positionnement stratégique de la marque

Il est essentiel de définir dès le départ :

- jeunes adultes, communautés LGBTQ+, consommateurs soucieux d’écologie, etc.
- inclusion, plaisir, accessibilité, santé sexuelle, engagement éthique…
- prix, canaux de distribution (pharmacie, e-commerce, grande distribution, etc.)
Coût estimé : 0 à 5 000 € (si réalisé en interne ou via un consultant branding indépendant)

2. Sourcing et sélection d’un fabricant (OEM)

La production est généralement externalisée auprès de fabricants certifiés ISO 13485, disposant de produits déjà marqués CE. Deux options s'offrent à vous :

- personnalisation du packaging uniquement
- forme, texture, dimensions, lubrifiants, parfums, etc.

Zones de production courantes : Inde, Malaisie, Thaïlande, Corée du Sud, Chine

Coût de production OEM : 0,04 € à 0,10 € / unité

Quantité minimale : souvent entre 100 000 et 300 000 unités

3. Mandataire européen (conformément au Règlement MDR 2017/745)

Si le fabricant est situé hors Union européenne, il est impératif de désigner un mandataire européen chargé de :

- Représenter légalement le fabricant auprès des autorités

- Valider la documentation technique, les étiquetages, les notices.

- Assurer la traçabilité, la vigilance post-commercialisation et la conformité continue

Coût moyen : 5 000 à 15 000 € / an

(Variable selon le volume, le nombre de références produits, et les exigences réglementaires)

4. Conformité des emballages et notices

L’emballage doit obligatoirement comporter les mentions suivantes :

- Marquage CE avec le numéro de l’organisme notifié

- Identité et coordonnées du fabricant

- Identité et coordonnées du mandataire européen

- Instructions d’utilisation en français

- Numéro de lot, date de péremption, conditions de conservation

Coût de développement packaging + notice : 2 000 à 5 000 €

(incluant design graphique, impression, relecture réglementaire)

5. Déclaration auprès de l’ANSM (France)

Avant mise sur le marché, le produit doit être déclaré à l’ANSM (Agence Nationale de Sécurité du Médicament) en tant que dispositif médical de classe IIb.

- Processus gratuit, mais nécessite un dossier technique solide et conforme.

- Il est recommandé de s’appuyer sur un expert réglementaire ou un cabinet spécialisé.

6. Logistique, stockage et distribution

Les options logistiques incluent :

- avec entrepôt physique (B2B ou e-commerce)

- externalisées (Amazon FBA, Cubyn, Bigblue…)

-Coût moyen : 0,10 € à 0,40 € / unité logée

(hors frais de transport, douane, etc.)

7. Lancement marketing & commercial

Le lancement commercial doit s'appuyer sur :

- site e-commerce performant (Shopify, WooCommerce, etc.)

- territoire de marque fort et un packaging différenciant

Budget marketing recommandé : 15 000 à 50 000 €

(selon les canaux, la durée de la campagne et les ambitions de notoriété)

Coûts estimés (ordre de grandeur)

Entre 35 000 et 90 000€

1. Fabrication OEM : 0,03 € – 0,15 € / unité selon le volume.
2. Mandataire européen : 2 000 – 10 000 € / an.
3. Tests de conformité / labos : 10 000 – 30 000 €
4. Dossier technique (si sous-traité) :10 000 – 25 000 €
5. Enregistrement ANSM (Agence nationale de sécurité du médicament) : 0€
6. Branding & packaging : 5 000 – 20 000 €

The largest condom brands in the world produce their products in various countries, primarily in Asia, where manufacturing facilities benefit from advanced technological expertise and economies of scale. :

1. Durex

• Production location : Durex, one of the best-known brands in the world, manufactures its condoms mainly in Thailand, China and India. Reckitt Benckiser, the parent company of Durex, has modern factories in these countries.

2. LifeStyles (formerly Ansell)

• Production location : LifeStyles (Skyn, Manix, Mates, Lifestyles brands) manufactures its condoms in Thailand, India, and Malaysia.

3. Condomz

• Location of production : Condoms from the French brand Condomz are made in India.

The place of manufacture does not affect the quality of condoms. All major brands have strict quality control procedures in place to ensure that each condom is safe and effective before being released to the market

1. Ritex

• Location of production :
• This brand of condom founded in 1948 is made in Germany.

2. Billy Boy

• Production location : The Billy Boy brand is another German brand founded in 1990 and manufactured by the MAPA GmbH laboratory. well known in Germany, it offers a wide variety of products that you can find here

There are French brands of condoms, such as Condomz, My Lubie, Soft, Intimy, Terpan Smile... but none of these condoms come from a French factory.

Several factors may contribute to condom manufacturing in Asia:

1. Labor Cost: Asian countries, especially those like China, India, and Malaysia, often have lower labor costs compared to other regions of the world. This makes manufacturing less expensive for companies.
2. Industrial Infrastructure: Many Asian countries have a well-developed industrial infrastructure for manufacturing rubber products and medical products, which facilitates the production of condoms.
3. Technical expertise: Some Asian countries have developed technical expertise in condom manufacturing, thanks to years of experience and investment in this sector.
4. Access to raw materials: Some Asian countries have easy access to raw materials needed to make condoms, such as natural latex.
5. Global Demand: Condoms made in Asia are often exported to other parts of the world due to the global demand for this product, making them a logistical and economical choice for many companies.

The largest condom manufacturer in the world is the Malaysian company Karex Industries. Karex is a leading global condom manufacturer and supplies products to many brands and distributors worldwide. such as Durex (belonging to Reckitt Benckiser), Pasante , Okamoto Industries, Thai Nippon Rubber Industry (JEX brand), notably

We have chosen to offer you brands each offering one or more added values, so that you can offer your customers, your patients, your students or your prevention operations, an objective vision of what exists.

Condoms are distinguished by different criteria.

1 - The material (with or without latex)

- Latex

Latex is a milky, viscous liquid produced by many plants, including the rubber tree, also known as the rubber tree. It contains a complex mixture of organic compounds, including proteins, carbohydrates and lipids. When latex is harvested from rubber trees, it is transformed into natural rubber through a coagulation process.

Condomz condoms are made from natural rubber latex

- Polyisoprene: for Skyn ​​condoms.

Polyisoprene is a synthetic polymer that belongs to the elastomer family. It is a material similar to natural latex in flexibility and strength, but it is synthetically produced. Polyisoprene is therefore used in the manufacture of condoms as an alternative to latex, as it offers a bare skin feeling and is suitable for people with latex allergies.

- Polyurethane

It is a synthetic polymer that is widely used in various fields due to its unique physical and chemical properties. We will find Lelo Hex condoms, female condoms as well as the original Skyn ​​condoms.

- Polyethylene: for female condoms

Polyethylene is a thermoplastic polymer widely used in various applications due to its excellent physical and chemical properties. It is one of the most commonly produced plastics in the world

- Nitrile : also for the female condom.

Nitrile is an organic chemical compound. I am found naturally in some plants, but it is usually produced synthetically on a large scale for a variety of industrial and commercial applications, including gloves.

2 - The price

Condoms have a unit price which varies between €0.15 and €2.

The cheapest condoms on the market remain condomz condoms. The founders of the brand took the challenge of offering a quality condom at a low price, so that it is accessible to as many people as possible.

A price is obviously defined by the communication effort and the investment reserved for this communication, but also the manufacturing. A non-latex condom, made of polyisoprene, is two to three times more expensive to manufacture than a latex condom.

3 - Conditioning

For economic, marketing or logistical reasons, manufacturers will make different packaging choices.

- Packages of 2, 3 or 4 for vending machines

- Packaging of 100 or 144, or 1000, in bags or boxes, in bulk or in pouches, for associations, sex workers, or to reduce production costs.

- Packaging of 10, 12, 20, 24 or 36 for traditional resellers (GMS, pharmacies, or merchant sites)

This packaging will be very refined for products intended for volume redistribution players, while it will respect marketing specifications to position a brand on its market.

4 - The offer of different sizes

Some brands offer at least two sizes, a 52mm nominal width, the so-called standard size, and a large size, around 56mm nominal width. Other brands will offer small sizes with a nominal width of 49 mm, which is the case with condomz and its “tailor-made” model. Brands like My Size pro will offer up to 8 to 10 sizes, from the smallest to the largest.

5 - The width of the range

There are single product brands (with one or two sizes) and others which offer a wide range of condoms, scented, textured, retardant, large size, ultra thin, latex free... which is the case with Lifestyles laboratories with its Manix and Skyn ​​brands.

6 - The ethical and environmental dimension

Condoms are Vegan as long as they do not contain casein (milk protein), which is the case for Manix, Skyn ​​and Condomz condoms. They are more respectful of the environment when the packaging contains less, little or no excess plastic, for example, the box is made from recycled cardboard. The brand will be more ethical if it uses fair trade latex, which is the case for example with the Condomz brand.

7- Its communication

The Condomz brand, for example, is a digital native vertical brand, it was born on the internet, it was first distributed to young people, and became known on social networks. It wants to be close to youth and community stakeholders. She advocates inclusion, respect for the LGBT community, consent, but her message remains the demystification of the condom, its use, and its qualities. We are not talking about sexuality, but only about condoms and prevention.

Other brands will have more medical communication oriented towards specialized distributors (pharmacy), others will take the part of speaking without taboo about sexuality, some are aimed more particularly at women.

8 - Its distribution network

Historically, in France, condoms were first sold in pharmacies, this medical device then found its place in supermarkets, or retailers, to arrive in specialized stores (Sexshops then loveshops), to finally be widely distributed on the internet. In 2012, the first online drugstores arrived, i.e. general distributors. Recently, brands are choosing to position their products on marketplaces.

Condomz.com is the first specialist site, put online in 2003. Then Manixshop.fr, and finally durexstore.fr, which became Durex.fr, then Skyn.fr.

9 - The anteriority of the brand

The iconic brand Durex was created in 1929 in London, while Manix is ​​a brand created in 1989, Skyn ​​arrived in 2008. The Condomz brand was born in July 2003.

Durex was bought in 2010 by the publicly listed English group Reckitt Benckizer, the group has invested enormously in communication and the development of its range. However, the Durex brand remains the most expensive brand on the market today.

The Ansell laboratory, creator of the Manix and Skyn ​​brands, sold its brands to the Lifestyles group in 2017. This company is not listed on the stock exchange but belongs to the Ansell Limited group, listed on the Australian stock exchange.

CondomZ belongs to the French SARL MBLAB, created in 2003, whose head office is in Montauban in Tarn et Garonne, its founders remain the only shareholders of the company, and probably among the oldest active players in this market.

10 - Its ability to innovate

We will recognize the largest brands on the market, Durex, Skyn ​​and Manix, for their ability to innovate on their product proposition. In this market, the communication of these major brands is essential with a young target to continue to accustom them to the systematic use of condoms. Without this omnipresence, the condom market would continue to decline year after year. It’s a product that requires a lot of communication.

In terms of innovation, we will cite the Lelo Hex brand and the hexagonal structure of its condom, making it more resistant and offering more sensations. The MySize brand has decided on a wide choice of sizes, from 47mm to 72mm nominal width.

We will try to enter the catalogs of other innovative brands.

It all depends on your distribution method.

For pharmacies where space is often lacking, it is advisable to offer the Skyn ​​range, with the Elite, King Size model, and the Skyn ​​Naurally Endless for lubricant, a water-based lubricant which gives good results. Manix lubricants remain essential, as well as Manix Endurance.

For commercial sites, it is necessary to reference the Skyn ​​range, latex-free remains a strong demand in the market today. Condomz condoms for affordable prices and customers looking for volume.

For associations , we would strongly advise you to work on volume and personalization (duo condoms/gel for example) we have an offer adapted for this. For discovery we have a wide range of specific products (internal condoms, perfumed, etc.).

More generally, we will be able to offer you an offer or products corresponding to your needs, challenge us.

contact us .

Voici une liste des principaux producteurs de préservatifs dans le monde, classés par taille, zone géographique et spécificités. Ces fabricants sont à l’origine de la majorité des marques (y compris sous marques distributeurs ou OEM).

1. Grands groupes industriels (multi-marques)

Karex Berhad – Malaisie

• Le plus grand fabricant mondial

• Production : >5 milliards de préservatifs/an

• Fabrique pour : Durex, ONE, marques distributeurs (Amazon, Carrefour, etc.)

Thai Nippon Rubber Industry (TNR) – Thaïlande

• Fabrique les préservatifs Okamoto, certains Skyn, et pour d’autres marques

• Forte capacité d’export

HLL Lifecare Ltd – Inde (publique)

• Principal fournisseur de préservatifs en Inde (marque Moods) + contrats ONU

• Grand acteur sur le marché humanitaire

Ansell / Lifestyles Healthcare – Australie / Singapour

• Marque : Skyn, Lifestyles, Manix, Blowtex

• Usines en Thaïlande, Inde, Brésil (selon la gamme)

Church & Dwight (Trojan) – États-Unis

• Usine à Colonial Heights, Virginie

• Produit les préservatifs Trojan (leader aux USA)

• Production locale et partiellement automatisée

2. Fabricants spécialisés OEM (produisent pour d’autres marques)

Unidus Corporation – Corée du Sud

• Fournisseur de nombreux MDD (marques de distributeurs)

• Certifications européennes et FDA

Cupid Limited – Inde

• Spécialisé dans les contrats gouvernementaux et ONG

• Marque propre et OEM

Richter Rubber Technology – Malaisie

• Fournisseur humanitaire

• Certifié CE, ISO, FDA

Humanwell Healthcare / Wuhan Jissbon – Chine

• Grand acteur en Chine

• Propriétaire de la marque Jissbon (très populaire en Asie)

3. Marques avec leur propre outil industriel

• LELO HEX : produit en Europe de l’Est (usine peu médiatisée)

• Glyde (Australie) : préservatifs véganes certifiés

• RFSU (Suède) : petite production scandinave

• Ritex (Allemagne) : rare fabricant européen, indépendant

Le marché mondial des préservatifs est en pleine expansion. En 2024, sa valeur est estimée à environ 10,2 milliards de dollars américains et devrait atteindre 15,13 milliards de dollars d'ici 2029, avec un taux de croissance annuel composé (TCAC) de 8,2 % sur cette période. ​Global Growth Insights+2Mordor Intelligence+2Global Market Insights Inc.+2

En France, le marché est d'environ 120 millions d'euros avec plus de 108 millions d'unités consommées annuellement. ​

Durex et Skyn se partagent 85% du marché en France.