Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A pre-lubricated catheter is a single-use intermittent urinary catheter supplied ready to use, with a lubricant gel or a lubricating coating already on the tube. On this page, “self-lubricating” and “no-touch” are mapped to the specific designs FDA documents describe, so buyers and clinic staff can tell the designs apart and read a product listing correctly.
Who uses it: the FDA records below describe catheters used by patients to drain urine from the bladder; clinic staff, supply buyers and students use the terms on this page to compare product types.
What a pre-lubricated catheter is
FDA defines the urological catheter device type as “a flexible tubular device that is inserted through the urethra” to pass fluids to or from the urinary tract (21 CFR 876.5130, checked 2026-10-30). Intermittent, straight catheters fall under product code EZD (“Catheter, Straight”), a Class II device (openFDA classification data, updated 2026-10-19).
“Pre-lubricated” describes a convenience feature, not a separate regulatory category. In the FDA 510(k) summary for the Liv Pre-lubricated Intermittent Catheter (K260502) it is described as a “ready to use, water based gel lubricated, PVC intermittent catheter with a straight tip.”
How it is built: gel, hydrophilic coating, closed system
Three designs sit behind the search terms people use. “Self-lubricating” is a trade phrase with no regulatory definition, and it does not appear in the two FDA summaries cited below.
Gel pre-lubricated
Water-based gel is already on the catheter. The K260502 summary describes a single-use catheter that is ethylene oxide sterilized and packaged as a disposable device.
Hydrophilic coated (often called self-lubricating)
A hydrophilic coating becomes slippery when wet. In the EZ-Protect Hydrophilic Closed System record (K251274), a water sachet pouch supplied with the catheter activates the coating.
Closed system (often called no-touch)
The same K251274 record describes a catheter self-contained with a collection bag and an introducer tip, “designed with the collection bag and introducer tip allowing the user to insert the catheter without having to touch the catheter.”
Types and variants
| Type | What the FDA record says | Key difference |
|---|---|---|
| Gel pre-lubricated, straight tip (K260502) | Ready to use, water-based gel lubricated PVC catheter; EtO sterilized; single-use disposable; Prescription only in the comparison table | Lubricant is already on the catheter |
| Hydrophilic closed system (K251274) | Sterile, single-use, hydrophilic coated PVC catheter, straight or coude tip, with water sachet and collection bag; Prescription only | Coating is activated by water; catheter is handled through the bag and introducer tip |
| Reusable intermittent system (product code SHV, 21 CFR 876.5120, DEN250023) | Class II; reusable after reprocessing, intended for single-patient reuse; may include lubricant | Not a single-use product; reprocessing is part of its use |
Other FDA 510(k) names under product code EZD show that these categories exist in the market: COMPACTCATH Lubricated Intermittent Urinary Catheter (K180738), Cure Catheter Closed System (K230400), AMSure Hydrophilic Intermittent Catheter (K181445) and PVC Hydrophilic Urethral Catheter (K220722).
Sizes and specifications that matter
| Product record | Length | Size range | Tip |
|---|---|---|---|
| Liv Pre-lubricated Intermittent Catheter (K260502), adult women | 3.75 in (effective length) | 8 Fr. to 14 Fr. | Straight |
| EZ-Protect Hydrophilic Closed System (K251274) | 16 in | 8 Fr. to 18 Fr. | Straight or coude |
These are the values in two specific FDA summaries, not universal ranges. Other products list their own lengths and sizes in their instructions for use.
How to choose
Only criteria stated in the FDA records are listed here:
- Labelling: both documented products are labelled Prescription only in their 510(k) comparison tables,.
- Single use or reusable: single-use catheters (K260502, K251274) and reusable systems (SHV, 21 CFR 876.5120) are different regulated products with different handling.
- Intended user and population: K260502 is indicated for female patients; K251274 is indicated “to drain urine from the bladder” and lists “None Known” for contraindications. Check each product’s own indications for use.
- Tip and length: straight versus coude tip and length are listed per product, as in the table above.
Safe use and handling basics
Follow the manufacturer’s instructions for use for the exact product. The documented single-use catheters are supplied sterile and labelled single use; the instructions for use govern storage, packaging checks and disposal. This page does not give insertion steps.
Common mistakes
- Treating the terms as interchangeable. “Pre-lubricated” (gel), “self-lubricating” (usually a hydrophilic coating) and “no-touch” (a closed system with a bag) describe different features, and one product can combine more than one.
- Confusing single-use with reusable. Reusable intermittent systems are classified separately (product code SHV) and are intended for reprocessing; single-use products are labelled disposable.
- Assuming one size range fits all products. The two records above differ in length (3.75 in versus 16 in) and in Fr. range.
FAQ
What is the difference between a pre-lubricated and a self-lubricating catheter?
A pre-lubricated catheter carries lubricant gel already on the tube (K260502). “Self-lubricating” is a trade phrase, most often used for hydrophilic coated catheters that are activated with water (K251274). It is not an FDA term.
What is a no-touch catheter?
FDA’s K251274 summary describes a closed system with a collection bag and introducer tip so the user can insert the catheter without touching it.
Is a pre-lubricated catheter sterile and single use?
The gel-lubricated catheter in K260502 is described as ethylene oxide sterilized and single-use disposable. Check the instructions for use of any specific product.
Does a pre-lubricated catheter need a prescription?
Both products documented here are labelled Prescription only in their 510(k) comparison tables. Labelling varies by product, so check the specific listing.
Browse hydrophilic catheters in the lac.us catalogue.
Related CASRAI guides
- Urinary catheter types
- Robinson catheter
- Urology clinic supply checklist
- Sterile lubricating jelly
- Foley versus suprapubic catheter
Sources
- 21 CFR 876.5130, Urological catheter and accessories: https://www.law.cornell.edu/cfr/text/21/876.5130 (checked 2026-10-30).
- openFDA device classification, product codes EZD and SHV (data updated 2026-10-19): https://api.fda.gov/device/classification.json?search=product_code:EZD and https://api.fda.gov/device/classification.json?search=product_code:SHV (checked 2026-10-30).
- FDA 510(k) K260502, Liv Pre-lubricated Intermittent Catheter: https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260502.pdf (checked 2026-10-30).
- FDA 510(k) K251274, EZ-Protect Hydrophilic Closed System Intermittent Catheter(s) and Kits: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251274.pdf (checked 2026-10-30).
- FDA 510(k) database entries K180738, K230400, K181445 and K220722 (product code EZD): https://api.fda.gov/device/510k.json?search=product_code:EZD (checked 2026-10-30).
