Medical-Grade Silicone Heritage — From Clinics to Horse Tack

Baby pacifier purity, horse-safe by default.

The Silicone Class That Touches Newborns Now Touches Your Horse.

12 years of FDA + LFGB medical-grade silicone for infusion sets, neonatal tubing and food-contact kitchenware — the exact same purity standard is in every Rubbrex Bit Guard.

Why Medical-Grade Matters for Horse Tack

Most horse tack sits on horse skin. Some horse tack — bit guards, muzzle pads — touches horse mouths, lips and gums. For those products, 'industrial silicone' isn't good enough. You need the same purity class used in baby pacifiers and medical infusion tubing: zero leachable monomers, zero heavy metals, zero off-gassing chemicals. That's the class Rubbrex produces across our entire equestrian line, not just the mouth-contact SKUs.

Medical-Grade Certifications We Carry

FDA 21 CFR 177.2600

Food-contact rubber articles — safest US classification for polymer-skin contact.

LFGB §31

The strictest European food-contact silicone standard — used for baby and kitchen products.

ISO 10993-5/10/23

Biocompatibility testing for medical devices — in vitro cytotoxicity, sensitisation, irritation.

USP Class VI

Pharmaceutical-grade material testing for long-term implant suitability.

Real Projects Behind the Heritage

Over 12+ years, our medical-grade division has served EU hospital procurement and food-contact kitchenware brands at scale. Every batch carries documented FDA / LFGB compliance paperwork, and every batch shares its raw material class with our equestrian products. Specific volume and customer references are available under NDA for serious OEM / ODM prospects.