Marco Rubber supplies FDA O-rings, FDA gaskets, FDA rubber seals and custom-designed components from a range of FDA compliant rubber materials, including FDA Buna-N, FDA EPDM, FDA Silicone, FDA Viton® and Markez® FFKM.
We are experienced with the demanding applications found in the Food and Drug regulated industries.
Selecting the best material or seal design can increase service life and predictability,
and reduce contamination, resulting in higher efficiency.
FDA O-Rings Compliant Food and Drug Administration FDA CFR 21.177.2600
The Food and Drug Administration is the US Federal Agency responsible for ensuring that food safety, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. Although the jurisdiction of the FDA is restricted to the United States, FDA regulations are commonly adopted as international control standards. Through its Codes of Federal Regulations the FDA manages a list of materials and chemicals that are approved for contact with foods.
FDA CFR 21.177.2600 paragraphs A through D describe the relevant regulations for 'Rubber articles intended for repeated use'. This lists the ingredients, and any quantitative limits, that may be used in a rubber compounds for molded products intended for repeated use in all stages of food manufacture, preparation and transportation.
FDA CFR 21.177.2600 paragraphs E and F also specify limits on extractible products if the FDA rubber seal is to be used in contact with aqueous or fatty foods. The regulation specifies extraction test limits in water and n-hexane. It is important to note that for an FDA rubber material to be compliant to these requirements, and then this claim must be supported with appropriate documentation such as a manufacturer's FDA Compliance Certificate.
FDA does not "approve" products to CFR 21.177.2600. It is for the manufacturer of the finished FDA rubber product to demonstrate compliance by issuing a FDA certificate. It is also important to note that whilst a component may be made from a FDA rubber material that is suitable for food contact; this does not mean that the part is technically suitable for its intended application.
Dry Foods (A-D)
FDA Requirement Must be formulated and cured under conditions of good manufacturing practice as to be suitable for repeated use.
Limit for Extractives No specified test.
Aqueous Foods (A-E)
FDA Requirement Must meet extraction test criteria (distilled water at reflux temperature).
Limit for Extractives First 7 hours: Not exceeding 20mg per square inch. Next 2 hours: Not exceeding 20mg per square inch.
Fatty Foods (A-F)
FDA Requirement Must meet extraction test criteria (n-hexane at reflux temperature).
Limit for Extractives >First 7 hours: Not exceeding 175mg per square inch. Next 2 hours: Not exceeding 4mg per square inch.
Popular Products
- O-rings, Micro and Giant
- Tri-Clamp Gaskets or Sanitary gaskets
- PTFE encapsulated O-rings
- X-rings and washers
- Custom Molded
Popular Materials
- FDA Compliant per CFR 21.177.2600
- USP Class VI Approved
- 3A Dairy Compliance
- NSF61, KTW and WRAS Approved
- Metal Detectable Materials
- ADI Free Materials
- LIM silicone per customer specification
- Clean Room Manufacturing and Packaging
Popular Compounds
Compound # | Datasheet | Material | Hardness (Shore A) | Color | Low Temp °F (°C) | High Temp °F (°C) | FDA* | USP Class VI** | NSF61 | USDA 3A | Metal Detectable | Features |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
E1000 |  | EPDM | 70 | Black | -65 (-54) | 300 (149) | Peroxide cured EPDM, Different Durometer, KTW, WRAS standards available | |||||
E1074 | | EPDM | 70 | White | -65 (-54) | 300 (149) | Wide range of compliance | |||||
E1080 | | EPDM | 70 | Black | -40 (-40) | 250 (121) | Wide range of compliance | |||||
E1097 | | EPDM | 70 | Black | -65 (-54) | 300 (149) | Formulated for Chloramine Resistance. Can be manufactured in custom shapes with minimal setup charge. | |||||
B1002 | | NBR | 70 | Black | -30 (-34) | 300 (149) | Available in many durometers and colors | |||||
B1039 | | NBR | 70 | White | -30 (-34) | 250 (121) | Available in many durometers and colors | |||||
B1058 | | NBR | 70 | Black | -30 (-34) | 250 (121) | KTW, WRAS and other standards available. | |||||
B1105 | | NBR | 70 | Black | -30 (-34) | 250 (121) | Metal detectable for contamination detection sensors(additional colors available) | |||||
S1000 | | VQM | 70 | Orange | -75 (-59) | 400 (204) | Available in many durometers and colors | |||||
S1020 | | VQM | 70 | Clear Translucent | -75 (-59) | 400 (204) | Clear Translucent, available in many durometer and color choices. | |||||
S1037 | | VQM | 70 | Clear Translucent | -75 (-59) | 400 (204) | Clean room manufactured, platinum cured (specific base materials and cleanroom packaging options available) | |||||
S1083 | | VQM | 70 | Clear Translucent | -65 (-54) | 400 (204) | Commercial manufactured, platinum cured (cleanroom manufacturing and packaging options available) | |||||
S1146 | | VQM | 70 | White | -75 (-59) | 480 (249) | Cleanroom manufactured, Lower cost than clear | |||||
V1039 | | FKM | 75 | White | -15 (-26) | 437 (225) | Cleanroom manufacturing and packaging options available | |||||
V1118 | | FKM | 70 | White | -15 (-26) | 437 (225) | Steam Resistant Terpolymer, Also available in black | |||||
V1148 | | FKM | 70 | Black | -15 (-26) | 392 (200) | Metal detectable for contamination detection(additional colors available) | |||||
Z1416 | | FFKM | 75 | Black | -5 (-21) | 610 (321) | FDA compliant, higher temperature resistance, wide chemical compatibility. Compare to Kalrez® 6230, Kalrez® LS222 | |||||
Z1703 | | FFKM | 75 | Black | 5 (-15) | 525 (274) | Greater temperate resistance range. Compare to Kalrez® 6230, Kalrez® LS222 | |||||
Z1318 | | FFKM | 75 | White | 5 (-15) | 500 (260) | USP Class VI and FDA compliant white FFKM with wide range compatibility. Compare to Kalrez® 6221, Kalrez® LS205, Chemraz® 625 |
The information on this page is to the best of our knowledge accurate and reliable. However, Marco Rubber makes no warranty, expressed or implied, that parts manufactured from this material will perform satisfactorily in the customer's application. It's the customer's responsibility to evaluate parts prior to use.
The temperature ranges presented on this page are approximations for dry air service only and should not be used to determine design specifications or end-use temperature limits. Actual temperature range of a compound in an end-use application is highly dependent on part type, hardware configuration, applied forces, chemical media, pressure and thermal cycling effects, and other factors. The most practical way of determining an end-use temperature range is testing in the actual application conditions. Consult a Marco Engineer for more details.
*FDA compliance per 21 CFR 177.2600 parts A-D, E&F approved compounds available upon request. **USP <87> and USP <88> approved compounds available upon request.
The temperature ranges presented above are approximations for dry air service only and should not be used to determine design specifications or end-use temperature limits. Actual temperature range of a compound in an end-use application is highly dependent on part type, hardware configuration, applied forces, chemical media, pressure and thermal cycling effects, and other factors. The most practical way of determining an end-use temperature range is testing in the actual application conditions. Consult a Marco Engineer for more details.
Marco Rubber & Plastics is an industry leader in custom sealing solutions that go beyond the limits of catalog commodities. Since 1980, our solutions have delivered reliable, long-lasting success for customers worldwide. We offer the largest inventory of specialty and standard sealing solutions backed by best-in-class technology, service and support.
