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Home / Materials / FDA/USP FKM
Material

FDA & USP Class VI FKM O-Rings for Regulated Chemical-Contact Sealing

FDA and USP Class VI compliant FKM combines FKM's broad chemical and fuel resistance with documented compliance for regulated food and pharmaceutical applications where hydrocarbon or chemical exposure exceeds silicone's suitability.

When to Select

When FDA/USP FKM Should Be Selected

Select FDA/USP Class VI FKM where a regulated process involves oils, fuels or chemical media beyond silicone's resistance, and documented compliance is required.

Advantages

Main Advantages

  • FKM-level chemical and hydrocarbon resistance with regulatory documentation
  • Suited to regulated processes with oil/fuel exposure that would degrade certified silicone or EPDM
Limitations

Important Limitations

  • Compliance applies only to the exact documented compound — confirm the required regulation at enquiry
  • Higher cost than standard non-certified FKM
Applications

Typical Industries

Pharmaceutical & BiotechFood, Beverage & Dairy
Media Compatibility

Suitable & Unsuitable Media

SUITABLE:
Regulated-process oils and fuelsChemical media within FKM's general resistance profile
UNSUITABLE / REQUIRES VERIFICATION:
Ketones, esters, amines (as with standard FKM)
Technical Data

Hardness, Temperature & Standards

Hardness65–85 Shore A
Temperature Range-20°C to 200°C continuous
Relevant Standards / CertificationsFDA 21 CFR 177.2600, USP Class VI — compliance applies only to the specific compound for which supporting documentation is provided.
Comparison

FDA/USP FKM vs. Alternative Materials

FDA/USP FKM extends FKM's chemical resistance into regulated environments; where chemical exposure exceeds FKM's profile, high-purity FFKM should be evaluated.

Available As

FDA/USP FKM Product Types

FDA/USP FKM O-Rings

Precision-molded circular seals available across FITCO's full specialty material range.

View O-Rings →
FAQ

FDA/USP FKM Frequently Asked Questions

Yes — the base polymer chemistry is similar to standard FKM, but the compound is manufactured and documented to meet FDA/USP Class VI requirements specifically.

Send Your Application Details

Share your fluid, temperature, pressure and certification requirement — FITCO will review and propose a suitable FDA/USP FKM compound.

Send Your Application Details
Material information is provided for preliminary guidance. Final material selection must consider the complete application, including fluid composition and concentration, temperature, pressure, movement, operating cycle, groove design and applicable regulatory requirements. FITCO helps customers identify suitable sealing materials based on application details; this does not constitute a compatibility guarantee.