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Short answer: “Not made with natural rubber latex” is the label wording the US Food and Drug Administration (FDA) recommends for a medical product, its container or its packaging when the manufacturer wants to say natural rubber latex was not used as a material. FDA discourages “latex-free” and “does not contain latex” because it is not possible to reliably assure that the allergens are absent. This page is general product information, not medical advice.
Definition and scope
The wording comes from FDA’s final guidance for industry, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex (Center for Devices and Radiological Health, December 2014, docket FDA-2013-D-0168; FDA page content current as of 24 August 2018; checked 30 October 2026). Its stated purpose is to recommend language that conveys natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. The guidance page lists animal and veterinary products, biologics, drugs and medical devices among the regulated products it touches.
A voluntary “not made with” statement is a different thing from the mandatory caution that 21 CFR 801.437 requires on devices that do contain natural rubber. The two are compared below.
Why “latex free” is discouraged
FDA’s guidance says statements such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are a concern because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. FDA adds that these terms may give users allergic to natural rubber latex a false sense of security, and recommends a consistent, scientifically accurate statement for all manufacturers who wish to convey that natural rubber latex was not used.
That is the practical answer to what “latex free” means on a medical label: it is a common shorthand, but not the wording FDA recommends, and it is a claim about absence rather than about the materials used.
Label wording compared
| Label state | Wording | Source |
|---|---|---|
| Required caution, product contains natural rubber latex that contacts humans | “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” | 21 CFR 801.437(d) |
| Required statement, product contains dry natural rubber that contacts humans | “This Product Contains Dry Natural Rubber.” | 21 CFR 801.437(e) |
| Required caution, packaging contains natural rubber latex that contacts humans | “Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” | 21 CFR 801.437(f) |
| Required statement, packaging contains dry natural rubber that contacts humans | “The Packaging of This Product Contains Dry Natural Rubber.” | 21 CFR 801.437(g) |
| Voluntary statement that natural rubber latex was not used | A consistent, scientifically accurate “not made with natural rubber latex” statement, covering the product, container and/or packaging | FDA guidance, December 2014 |
| Wording FDA considers inaccurate | “latex-free,” “does not contain natural rubber latex,” “does not contain latex” | FDA guidance, December 2014 |
| Prohibited on devices that contain natural rubber that contacts humans | The term “hypoallergenic” | 21 CFR 801.437(h) |
The regulation text was checked on 30 October 2026 in the eCFR. The section applies to devices composed of or containing, or having packaging or components that are composed of or contain, natural rubber that contacts humans. The section itself contains no provision for a “latex free” claim.
What counts as “natural rubber” in the regulation
Under 801.437(b), the term “natural rubber” includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation. “Natural rubber latex” is rubber produced by the natural rubber latex process, which uses natural latex in a concentrated colloidal suspension; products are formed by dipping, extruding or coating. “Dry natural rubber” is made from coagulated natural latex in dried or milled sheets and formed by compression molding, extrusion, or by converting the sheets into a solution for dipping.
“Contacts humans” is defined broadly: the natural rubber is intended or likely to contact the user or patient, including when the device is connected to the patient by a liquid path or an enclosed gas path, or when the device is coated with a powder that may carry natural rubber proteins and contaminate the user’s or patient’s environment.
Where it matters for labs, clinics and supply decisions
FDA’s medical gloves page states that some people are allergic to the natural rubber latex used in some medical gloves, and that manufacturers must identify on the package labeling the materials used to make the medical gloves. The page was checked on 30 October 2026. For glove materials in detail, see what a latex glove is, chloroprene gloves and the nitrile, latex and vinyl glove comparison. A product-specific example of the same label question is covered in latex-free kinesiology tape.
A label-reading checklist drawn from the sources above
- Find the materials statement on the package labeling; for medical gloves, FDA says manufacturers must provide it.
- Note whether the wording is the “not made with natural rubber latex” form FDA recommends or a “latex-free” or “does not contain latex” form FDA considers inaccurate.
- Check what the statement covers: the guidance addresses the product, its container and/or its packaging, so the claim can concern more than the device itself.
- Look for an 801.437 caution on the product and, separately, on the packaging; the packaging statements in (f) and (g) are distinct from the device statements in (d) and (e).
- Treat a “hypoallergenic” claim on a device that contains natural rubber contacting humans as a labeling problem, since 801.437(h) prohibits the term there.
Common misunderstandings
“Synthetic means it is not natural rubber”
In 801.437 the defined term “natural rubber” also covers synthetic latex or synthetic rubber that contains natural rubber in its formulation. A material called synthetic is not automatically outside the regulation, so the label and the materials statement matter more than the general name.
“Hypoallergenic means latex-safe”
The regulation bars the term “hypoallergenic” on the labeling of devices that contain natural rubber contacting humans, so it is not a reliable signal either way on those devices.
“Is there a latex-free symbol?”
Neither the FDA guidance nor 21 CFR 801.437 prescribes a symbol; both concern label wording. A symbol alone is therefore not the statement FDA recommends.
FAQ
What does “not made with natural rubber latex” mean?
It is FDA’s recommended way for a manufacturer to say that natural rubber latex was not used as a material in the product, its container and/or its packaging (FDA guidance, December 2014).
What does latex free mean, and what is the definition?
Commonly it is used to say a product has no natural rubber latex. FDA considers “latex-free” inaccurate wording for medical products because absence of the allergens cannot be reliably assured.
What products contain latex?
FDA does not publish a product list in the sources cited here. They establish that 21 CFR 801.437 applies to devices, packaging or components containing natural rubber that contacts humans, and that some medical gloves are made with natural rubber latex. Product labeling is where the material is stated.
Is there a latex-free symbol?
Neither the FDA guidance nor 21 CFR 801.437 prescribes one. The guidance addresses label wording.
Sources
- FDA, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex, December 2014, checked 30 October 2026.
- 21 CFR 801.437, User labeling for devices that contain natural rubber, checked 30 October 2026.
- FDA, Medical Gloves, checked 30 October 2026.
