Condom Manufacturers | Latex & Polyurethane OEM Sourcing

QQIP Editorial · Updated 10 October 2026

Condoms are medical devices

In the EU, condoms are Class IIb medical devices under MDR (EU) 2017/745, Annex VIII Rule 15, which requires a notified body. In the US, condoms are Class II devices under 21 CFR 884.5300 and need FDA 510(k) clearance; latex condoms must carry expiration dating under 21 CFR 801.435. Ask for the certificate or clearance that names the exact product, not a factory-wide document.

Latex and synthetic follow different standards

Natural rubber latex condoms are tested to ISO 4074; the 2026 edition replaces the 2015 one, so check which version your regulator references. Condoms made from synthetic materials such as polyurethane are tested to ISO 23409. Hynaut Black Gold 003 is latex; Hynaut Polyurethane 001 is polyurethane and cites a Chinese industry standard on its artwork.

“003” and “001” are names, not measurements

The numbers suggest film thickness, but the model name does not prove it. If thickness is part of your claim, require a test report on your batch. Published nominal widths are 52 ± 2 mm for Black Gold 003 and 53 mm for Polyurethane 001.

Shelf life and packs

Hynaut’s artwork gives five years’ storage or use for both models, and the pack sizes are 8 and 5. Check the expiry on every batch at receipt and confirm whether you need different pack sizes for your market.

Frequently asked questions

Can I sell these under my own brand?

Private-label condoms need regulatory documents that cover your brand and market. Confirm with Hynaut what it can supply.

Is polyurethane suitable for latex-allergic users?

Polyurethane is not latex, but any allergy or protection claim must be supported by the product’s regulatory file.

Has QQIP tested these condoms?

No. Widths and shelf life come from Hynaut’s artwork; request batch test reports.

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