Written and maintained by CASRAI Editorial Board
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General product information only, not medical advice. It does not replace a manufacturer’s instructions for use or the guidance of your clinical or procurement team.
Short answer
Polyolefin is a family of plastics made from olefin (alkene) monomers such as ethylene and propylene; polyethylene and polypropylene are the best-known members. In medical supplies the word can appear on IV bag and film labelling. It names a polymer family, not one specific material, so it does not tell you which resin, grade or sterilization method a product uses.
Definition and scope
A polyolefin is a polymer built from olefins, hydrocarbons with a carbon-carbon double bond. The U.S. FDA’s food-contact rule, 21 CFR 177.1520, does not use the word “polyolefin” itself; it regulates “olefin polymers” and defines them as basic polymers made as described in paragraph (a) of that section. That paragraph is a useful, citable picture of what the family contains.
The rule is a food-contact regulation. It is not a medical device clearance and says nothing about whether a bag, film or tubing is suitable for patient use.
Polyolefin plastic: what the family includes
According to 21 CFR 177.1520(a) (checked 2026-10-30), the olefin polymers it lists are:
| Listed in 177.1520(a) | How the rule describes it |
|---|---|
| Polypropylene and propylene homopolymer | Made by catalytic polymerization of propylene (the homopolymer with a metallocene catalyst) |
| Polyethylene (and fumaric acid-grafted polyethylene) | Made by catalytic polymerization of ethylene; the grafted version is then reacted with fumaric acid |
| Olefin basic copolymers | Copolymers of two or more 1-alkenes with 2 to 8 carbon atoms, with minimum weight-percent limits for ethylene and/or propylene units |
| Poly(methylpentene) | Made by catalytic polymerization of 4-methylpentene-1 |
| Polyethylene graft copolymers; ethylene-maleic anhydride copolymers | Polyethylene or ethylene copolymers with the stated grafted or comonomer limits |
The same section gives density ranges in its specifications: 0.880 to 0.913 g/cm³ for polypropylene and 0.85 to 1.00 g/cm³ for the polyethylene entries. Two products can both be “polyolefin” and still differ in density, stiffness and heat behaviour.
Polyolefin vs polyethylene
Polyethylene is one member of the family, so the two words are not interchangeable. The comparison polyolefin vs polyethylene sets out the relationship, and what is polyethylene covers that single polymer.
Polyolefin film in a real medical clearance
Polyolefin film shows up in medical bags. FDA’s 510(k) decision letter and summary for K223674 (eZSURE Empty Fluid Container, 21 CFR 880.5025 I.V. Container, class II, product code KPE, dated August 2, 2023) compares the new device with its predicate. The summary says both use a highly transparent, clear, flexible plastic film, intended as primary medical film for the bag body of IV bags, described as free of PVC, plasticizers, adhesives and latex, and both suitable for ethylene oxide (EO) sterilization. The film named in the comparison is a Sealed Air medical packaging film, grade M315, listed as polyolefin. It is cited here only as the example in that one clearance, not as an endorsement.
The same summary shows why the label word is not the whole story: the ports differed (the predicate used PVC not made with DEHP; the subject device used a thermoplastic elastomer), and FDA found that this raised no additional questions of safety or performance for that device. That finding applies to that device only.
Reading polyolefin on a label
Labelling is best read literally. The questions below come from what the sources above show:
- Does the documentation name the resin or film grade, or only say “polyolefin”?
- Do the instructions for use state the sterilization method (the K223674 summary names EO for that device)?
- Do the bag body, ports and tubing share the same material? In K223674 they did not.
- Is a “free of PVC” statement made for the whole device or only for the film?
For the stocking context, see IV bags and fluid types for institutional stocking. For heat tolerance of common plastics, see which plastics are autoclavable; a polyolefin label alone does not answer that question. For background, see what is polymer science.
Common misunderstandings
- Polyolefin means polyethylene. Polyethylene is one member; polypropylene and olefin copolymers are others under the same FDA rule.
- Polyolefin film is only shrink wrap. The K223674 summary describes polyolefin film as the bag body of an IV container.
- The food-contact rule clears it for medical use. 21 CFR 177.1520 concerns articles in contact with food; device clearance is a separate FDA process.
- “Non-PVC” describes every component. In K223674 the film and the port materials differed.
FAQ
What is polyolefin?
A family of plastics made from olefin monomers, including polyethylene and polypropylene.
What is the meaning of polyolefin on a label?
It names the polymer family. It does not identify the specific resin, grade, additives or sterilization method; check the product documentation.
Is polyolefin plastic the same as polyethylene?
No. Polyethylene is one polyolefin. See polyolefin vs polyethylene.
What is polyolefin film used for in medical supplies?
One FDA 510(k) summary (K223674) describes it as the film for the bag body of an IV container, free of PVC, plasticizers, adhesives and latex and suitable for EO sterilization. Other products may differ.
Sources
- U.S. FDA, 21 CFR 177.1520 Olefin polymers: https://www.law.cornell.edu/cfr/text/21/177.1520 (checked 2026-10-30).
- U.S. FDA, 510(k) K223674 decision letter and summary, eZSURE Empty Fluid Container, August 2, 2023: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223674.pdf (checked 2026-10-30).
