FDA 510K-Certified Lubricant Manufacturers: 2025 Sourcing Guide for Buyers

🔍 Key Compliance Requirements for US Market Entry

▮ All personal lubricants sold in North America must be FDA 510K certified 

▮ Applies to all formulations: 

   ▸ Water-based (💧) 

   ▸ Silicone-based (🛢️) 

   ▸ Oil-based (⛽) 

 Critical Benefits: 

✓ Guarantees product safety and performance 

✓ Meets FDA medical device standards 

✓ Mitigates legal and brand risks 

 📊 Market Intelligence for Procurement Teams

⚠️ Certification Challenges in China

◼ Limited to only 4 certified manufacturers 

◼ Significant barriers to entry: 

• $20K-$30K upfront costs
• 1-3 year approval process
• Annual compliance fees
• Rigorous facility standards

 🏆 Competitive Brand Landscape

Leading brands sourcing from certified manufacturers: 

▸ Pjur 

▸ Adam & Eve 

▸ Shibari 

▸ ID 

✅ Verified FDA 510K Certified Suppliers In China

1. Pingchuang Medical Technology

▫️ Established: 2012 

▫️ Location: Guangdong, China 

▫️ Workforce: 200 

▫️ Certified Products: 

   – Water-based lubricants 

   – Flavored varieties 

   – Silicone-based formulas 

▫️ Services: Full OEM capabilities 

🌐 www.pingchuangmed.com 

2. Dongguan Boyabio

▫️ Established: 2014 

▫️ Location: Guangdong, China 

▫️ Workforce: 200 

▫️ Specializations: 

   – Anal sex lubricants 

   – Water-based formulas 

▫️ Services: Private label programs 

🌐 www.boyabio.com 

 

3. Health & Beyond  

▫️ Established: 2009 

▫️ Location: Jiangsu, China 

▫️ Workforce: 500 

▫️ Advantages: 

   – Competitive pricing 

   – Complete ODM/OEM solutions 

   – Large-scale production 

🌐 www.healthandbeyond.com 

 

 4. Bath Concept Cosmetics  

▫️ Established: 2006 

▫️ Location: Guangdong, China 

▫️ Workforce: 500 

▫️ Expertise: 

   – Sensitive skin products 

   – Premium silicone lubricants 

   – Innovative R&D 

🌐 www.bathconceptc.com 

 

🤝 Strategic Sourcing Support

Our China-based procurement services include: 

✔ Factory vetting and validation 

✔ Regulatory compliance verification 

✔ Bulk pricing optimization 

✔ Quality assurance management 

✔ Supply chain coordination 

 

📩 Contact our sourcing specialists today: 

[Contact us to help you build business relationship with above lube factory]