WHO approved condom manufacturers list
WHO Approved Condom Manufacturers List & Global Sourcing Guide
Sourcing latex condoms that comply with WHO (World Health Organization) and UNFPA (United Nations Population Fund) standards is critical for government tenders, global public health programs, and commercial brands.
Whether you are looking for a certified WHO/UNFPA compliant latex condom supplier or seeking direct OEM/ODM factory manufacturing, this guide explains the compliance requirements, testing standards, and direct sourcing options from China.
What Does WHO/UNFPA Condom Compliance Mean?
To be listed or recognized under WHO/UNFPA specifications, a condom manufacturer must meet the most stringent international medical device regulations. These standards ensure structural safety, pinhole-free reliability, and biocompability.
Key International Quality & Regulatory Standards:
• ISO 4074 Standard: The ultimate international specification for natural rubber latex male condoms, governing dimensions, bursting volume/pressure, and freedom from holes. • ISO 13485 Certification: The global quality management system specific to medical device manufacturing. • CE Mark (MDR Compliance): Required for medical device distribution across European Union markets. • US FDA 510(k) Clearance: Essential for importing and selling latex condoms in the United States. • WHO/UNFPA Prequalification (PQ): Strict audits covering factory GMP (Good Manufacturing Practice), raw material sourcing, and batch-by-batch laboratory testing.
How to Verify a Condom Manufacturer’s Qualifications
When evaluating factory suppliers against the WHO approved condom manufacturers framework, global buyers should verify the following four elements:
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100% Electronic Testing: Every single condom must undergo 100% individual high-voltage electronic testing for pinholes before foil packaging.
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Air Burst & Water Leakage Tests: Batch testing for burst volume (minimum 18 liters) and burst pressure, as well as water tightness tests.
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Raw Material Traceability: Premium natural rubber latex sourcing to guarantee elasticity, shelf life (up to 5 years), and low protein levels.
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Cleanroom Manufacturing: Production and packaging conducted in controlled ISO Class cleanrooms to prevent contamination.
Shandong Ming Yuan Latex Co., Ltd. – Your Trusted OEM/ODM Condom Manufacturer
As a specialized latex condom manufacturer in China, Shandong Ming Yuan Latex Co., Ltd. operates under strict ISO 13485 and ISO 4074 quality control systems. We support global health organizations, pharmaceutical distributors, and private brands with high-quality, fully customizable latex condoms.
Our Factory & OEM Manufacturing Capabilities:
• Product Range: Ultra-thin condoms, textured (ribbed & dotted) condoms, colored & flavored condoms, delay condoms, and large-size condoms. • Full Customization: Customized foil shapes (square, round, rectangular), custom printed boxes, displays, and private label branding. • Strict Quality Assurance: Advanced automatic production lines with 100% electronic pinhole testing and rigorous laboratory batch verification. • Global Export Experience: Extensive export experience serving markets across Africa, Southeast Asia, Europe, Latin America, and the Middle East.
Request Factory Audit Documents & Free Samples
Need official compliance documentation, ISO certificates, or direct factory quotes for your tender/brand? Contact Shandong Ming Yuan Latex Co., Ltd. today to discuss your OEM specifications or request factory samples.
Welcome contact us by email: [email protected] or [email protected]
