FDA 510K-Certified Lubricant Manufacturers: 2025 Sourcing Guide for Buyers
June 28, 2025 by
ellenyi@adultstoysgd.com
Product Knowledge🔍 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
2. Dongguan Boyabio
▫️ Established: 2014
▫️ Location: Guangdong, China
▫️ Workforce: 200
▫️ Specializations:
– Anal sex lubricants
– Water-based formulas
▫️ Services: Private label programs
3. Health & Beyond
▫️ Established: 2009
▫️ Location: Jiangsu, China
▫️ Workforce: 500
▫️ Advantages:
– Competitive pricing
– Complete ODM/OEM solutions
– Large-scale production
4. Bath Concept Cosmetics
▫️ Established: 2006
▫️ Location: Guangdong, China
▫️ Workforce: 500
▫️ Expertise:
– Sensitive skin products
– Premium silicone lubricants
– Innovative R&D
🤝 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]
Latest Articles
August 5, 2025
How to Get Google Ads Approval for Adult Toys Successfully?
🎯 Problem, Agitation, Solution (PAS) Introduction ✔ Problem: 95% of adult toy brands face instant Google Ads rejections due to
August 4, 2025
How to Enter Religious Markets with Adult Products in 2025 Without Legal Risks?
🚨 Problem: Religious countries often impose strict bans or heavy restrictions on adult products due to cultural and moral values.
August 3, 2025
How to Eliminate Surface Imperfections in Men’s Strokers（ Masturbator )
🔍 Problem Statement For years, manufacturers of men’s strokers have struggled with tiny surface imperfections (pits/craters) caused by: Material limitations
August 2, 2025
Best Fidget Toys for Adults with Anxiety: How to Reduce Stress and Stay Focused?
🌪️ Anxiety & Stress: A Modern Struggle Anxiety and stress are challenges many adults face in today’s fast-paced world. Whether