Medical-Grade Silicone & FDA-Compliant Household Rubber Components
At N.K. Rubber (M) Sdn. Bhd., we produce safe, high-purity, and durable rubber and silicone solutions designed specifically for the demanding medical, healthcare, and consumer household appliance sectors. We specialize in compounding materials that meet strict international regulatory standards, ensuring zero toxicity, excellent chemical resistance, and long-term durability.
USP Class VI Medical-Grade Silicone Components
We specialize in manufacturing high-purity medical-grade silicone components for critical healthcare devices, surgical tools, and laboratory equipment. Using platinum-cured liquid silicone rubber (LSR), our biocompatible components offer excellent tear strength, zero odor, and complete structural stability under autoclave steam sterilization.
FDA-Compliant Food-Grade Silicone & Kitchenware
Our consumer products division manufactures food-grade silicone kitchenware and container seals that are 100% non-toxic and BPA-free. Formulated to resist food acids, household detergents, and extreme thermal cycles, these custom molded seals preserve airtight freshness in premium kitchenware products.
High-Durability Rubber Gaskets for Household Appliances
To prevent water and steam leaks in modern home utilities, we produce custom household appliance rubber seals. Designed for washing machines, water purifiers, vacuum cleaners, and coffee makers, our ozone-resistant seals maintain a secure, leak-free compression fit across years of continuous daily operation.
Controlled Manufacturing & Global Regulatory Standards
Fulfilling strict consumer safety and medical protocols, we employ dedicated cleanroom silicone molding environments for sensitive components. Our raw materials are completely traceable and fully compliant with FDA, USP Class VI, RoHS, and REACH guidelines, preventing component contamination.
Our Household & Medical Material Capabilities
To meet international public health, medical device, and food safety standards, our silicone and rubber materials are formulated and validated against strict global guidelines:
- Primary Material Classifications: Platinum-Cured Liquid Silicone Rubber (LSR), High-Consistency Rubber (HCR), FDA-Approved EPDM, and Food-Grade Nitrile (NBR).
- Global Regulations Met: FDA 21 CFR 177.2600 (Food Contact), USP Class VI (Biocompatibility), German LFGB compatibility, RoHS Directive, and REACH Compliance.
- Common Applications Supplied: Medical Device Diaphragms, Surgical Mask Seals, Baby Bottle Nipples, Blender Jar Gaskets, Water Filter O-Rings, Coffee Machine Tubing Adapters, and Ophthalmic Droppers.
FDA-compliant food-grade silicone kitchenware seals and airtight container gaskets.
Custom molded biocompatible medical-grade silicone components and device seals.
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