California Proposition 65: Safe Drinking Water and Toxic Enforcement Act of 1986
WHAT IS PROPOSITION 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65 is a California-specific “right-to-know” law. The law requires businesses to inform California residents through clear and reasonable warnings about exposures to chemicals known to the state to cause cancer, birth defects or reproductive toxicity.
PRODUCT SAFETY
This warning does not mean that the products listed are in violation of product safety standards or requirements. Our quality management system, which includes the design, development, and manufacture of product(s) by Southmedic, is certified as being in conformity with ISO 13485:2016 by Intertek, among other internationally recognized standards relevant to the product safety. See list of held certificates here.
As Proposition 65 chemicals are being updated annually, Southmedic continues to reasonably assess our supply chain for the presence of the listed chemicals as defined by OEHHA. Southmedic is committed to communicate warnings to our customer base, which consists of hospitals and distributors, such that California-based residents are clearly, and reasonably warned prior to exposure. Our products are not sold directly to consumers and are intended to be administered through health care professionals only.
CALIFORNIA WARNING ONLY
We are issuing a warning, in accordance with Proposition 65 requirements, by means of this correspondence. Please ensure that anyone who may come into contact with these products are provided warning prior to exposure.
CALIFORNIA WARNING: These products can expose you to chemicals, including Vinyl Chloride, which is known to the State of California to cause cancer or reproductive toxicity. For more information go to www.P65Warnings.ca.gov.
| Listed Chemical | Use | Subject Product(s) |
| Ethylene Oxide | Sterilant | Sterile scalpels |
| Vinyl Chloride | Residual monomer present in PVC-based raw materials | Respiratory Therapy Devices |
For any questions regarding the application of Proposition 65 on Southmedic’s products, please refer to our contact page.
If you have further questions regarding Proposition 65, contact the California Office of Environmental Health Hazard Assessment at www.p65warnings.ca.gov, or by phone at 1-916-445-6900.