GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

K252943 · Convatec Limited · EZD · Apr 1, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K252943
• Device Name: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
• Applicant: Convatec Limited
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Apr 1, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K252943 · Apr 1, 2026	GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women	Convatec Limited	Post-market patient comfort questionnaires	The sponsor conducted a post-market study using patient comfort questionnaires to support claims regarding the comfort of the FeelClean™ Technology used in the intermittent catheters.	Patient comfort; Post-market study; Patient-reported outcomes

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Post-market study (patient comfort); Post-market observational study	Patients using the intermittent catheters	Not applicable for this study	Patient comfort

Indications for Use

GentleCath™ Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Air for Women: Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

Device Story

Hydrophilic intermittent urinary catheters; used for bladder drainage in patients with urinary retention or dysfunction. Devices feature FeelClean™ Technology to enhance lubricity and reduce friction during insertion/withdrawal. Operated by patients or caregivers; used in clinical or home settings. Input is manual insertion into the urethra; output is drainage of urine from the bladder. Benefits include improved patient comfort and ease of use. Modifications include sterilization method change to X-ray, minor material formulation adjustments, and updated dimensional tolerances for eyelets.

Clinical Evidence

Post-market study including patient comfort questionnaires provided to support comfort claims. Bench testing included in vitro and ex vivo coefficient of friction and insertion/withdrawal force testing. Sterilization validation and stability testing performed to support shelf life extension.

Technological Characteristics

Hydrophilic intermittent catheters. Tube material: Hydrophilic Thermoplastic Elastomer (TPE). Funnel materials: PVC + DEHT or HDPE + EVA. Sterilization: X-ray (SAL 10^-6). Features FeelClean™ Technology. Dimensions: 90mm to 405mm lengths; CH08-CH18 diameters. Straight or Coudé tips. Single-use.

Indications for Use

Indicated for intermittent bladder drainage in adults (Men/Women) and pediatric patients with urinary retention or dysfunction of the urinary system.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• GentleCath Air for Men (K213283)
• GentleCath Glide Intermittent Catheter (K181206)
• GentleCath Air for Women (K232665)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 1, 2026

Convatec Limited
Danielle Gibboney
Sr. Regulatory Affairs Specialist
First Avenue
Deeside Industrial Park
Deeside Flintshire, GB CH5 2NU
United Kingdom

Re: K252943
Trade/Device Name: GentleCath™ Air for Men; GentleCath™ Glide Intermittent Catheter; GentleCath™ Air for Women
Regulation Number: 21 CFR§ 876.5130
Regulation Name: Urological Catheter and Accessories
Regulatory Class: II
Product Code: EZD
Dated: March 2, 2026
Received: March 2, 2026

Dear Danielle Gibboney:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252943 - Danielle Gibboney
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K252943 - Danielle Gibboney
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JESSICA K. NGUYEN -S

Jessica K. Nguyen, Ph.D.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252943 | |
| Device Name GentleCath™ Air for Men GentleCath™ Glide Intermittent Catheter GentleCath™ Air for Women | |
| Indications for Use (Describe) GentleCath™ Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Air for Women: Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K252943
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# 510(k) Summary

| Date Prepared | April 1, 2026 |
| --- | --- |
| Submitter | Convatec Limited
First Avenue
DEESIDE INDUSTRIAL PARK
Deeside Flintshire, GB CH5 2NU |
| Contact Person | Danielle Gibboney
Sr. Regulatory Affairs Specialist
E-mail: [e-mail] |
| Name of Device | GentleCath™ Air for Men, GentleCath™ Glide Intermittent Catheter,
GentleCath™ Air for Women |
| Device Common Name | Catheter, Urethral |
| Device Product Code | EZD |
| Classification Name | Urological catheter and accessories |
| Device Classification | Class II |
| Classification Regulation | 21 CFR 876.5130 |
| Predicate Devices | GentleCath Air for Men (K213283)
GentleCath Glide Intermittent Catheter (K181206)
GentleCath Air for Women (K232665) |
| Device Description | The subject intermittent catheters are the same or slightly modified from the predicate catheters with additional claims included for the specific hydrophilic surface technology (FeelClean™ Technology) used for these catheters. These devices are sterile, single-use, hydrophilic intermittent urinary catheters intended for bladder drainage in patients requiring intermittent catheterization. All three devices share the same fundamental intended use and technological characteristics as described in their respective cleared submissions. |
| Indications for Use | GentleCath Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. |

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K252943
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| | GentleCath Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath Air for Women: Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. |
| --- | --- |
| Technological Comparison | The subject device is substantially equivalent to the identified predicate device(s) with respect to intended use, design, technological characteristics, and performance. The modifications described in this submission, including the proposed additional claims for FeelClean™ Technology, do not alter the fundamental scientific technology or raise different questions of safety or effectiveness. Refer to Table 1 for a detailed technological comparison between the subject and predicate catheters. |
| Performance Data | Non-clinical testing and clinical information were provided to support the proposed claims for the FeelClean™ Technology and modifications to the predicate devices, including (1) in vitro and ex vivo coefficient of friction testing and insertion/withdrawal force testing for the friction force and lubricity claims; (2) a post-market study including patient comfort questionnaires for the comfort claim; (3) sterilization validation on the proposed sterilization method change and prolonged stability testing to support the proposed shelf life extension. The proposed modifications do not significantly affect the safety or effectiveness of the device, and the devices are substantially equivalent to their predicate devices. |
| Conclusion | The data and information provided in this submission support that the subject device (including GentleCath™ Air for Men, GentleCath™ Glide Intermittent Catheter, and GentleCath™ Air for Women) is substantially equivalent in safety and performance to the predicate devices cleared under K213283, K181206, and K232665. |

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K252943
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convatec
-- forever caring --

Table 1: Substantial Equivalence Comparison Table

| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison |
| --- | --- | --- | --- | --- | --- |
| Name of Device | GentleCath Air for Men | GentleCath Air for Men Hydrophilic Intermittent Catheter | GentleCath Glide Urinary Intermittent Catheter | GentleCath Air for Women | N/A |
| Product Code | EZD | GBM | GBM | EZD | N/A |
| Device Classification | Class II | Class II | Class II | Class II | Same |
| Device Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CRF 876.5130 | 21 CFR 876.5130 | Same |
| Intended Use/Indications for Use | GentleCath Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage | Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. | Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra. | Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. | Similar.
The subject device includes all 3-predicate devices into one submission. The indications for use of GentleCath Air for Men and GentleCath Air for Women remain unchanged from their predicate device. The language of the |

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K252943
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convatec
-- forever caring --

| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison |
| --- | --- | --- | --- | --- | --- |
| | due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath Air for Women: Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. | | | | indications for use of GentleCath Glide is modified to align with the indications of GentleCath Air for Men and GentleCath Air for Women. |
| Tube Material | GentleCath Air for Men: Hydrophilic Thermoplastic Elastomer (TPE)
GentleCath Glide Intermittent Catheter: Hydrophilic TPE
GentleCath Air for Women: Hydrophilic TPE | Hydrophilic TPE | Hydrophilic TPE | Hydrophilic TPE | Same.
The subject device includes all 3-predicate devices into one submission. They all have the same tube material. |
| Funnel Material | GentleCath Air for Men: Polyvinyl chloride (PVC) + Di(2-ethylhexyl) terephthalate (DEHT)
GentleCath Glide Intermittent Catheter: PVC + DEHT | PVC + DEHT | PVC + DEHT | HDPE + EVA | Slightly Different.
In K252943, the raw material of the HDPE used in GentleCath Air for Women does not include a specific additive present in the formulation of the |

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K252943
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| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison |
| --- | --- | --- | --- | --- | --- |
| | GentleCath Air for Women: High-Density Polyethylene (HDPE) + Ethylene-vinyl acetate (EVA) | | | | HDPE raw material for the predicate device (K232665). Removal of trace amount of specific additive from the funnel raw material formulation would not change the device performance or biocompatibility profile. |
| Length | GentleCath Air for Men: 405mm
GentleCath Glide Intermittent Catheter: Male: 405mm
Female: 150-200mm
GentleCath Air for Women: 90mm | 405 mm | Male: 405mm
Female: 150-200mm | 90mm | Same |
| Catheter Tube Outer Diameter (mm) | GentleCath Air for Men: CH08-CH16
GentleCath Glide Intermittent Catheter: Male: CH08-CH18
Female: CH08-CH16
GentleCath Air for Women: CH10-CH14 | CH08-CH16 | Male: CH08-CH18
Female: CH08-CH16 | CH10-CH14 | Same |

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K252943
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| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison |
| --- | --- | --- | --- | --- | --- |
| Eyelets | GentleCath Air for Men: 2 Smooth eyelets on opposite sides
GentleCath Glide Intermittent Catheter: 2 Smooth eyelets on opposite sides
GentleCath Air for Women: 2 Smooth eyelets on opposite sides | 2 Smooth eyelets on opposite sides | 2 Smooth eyelets on opposite sides | 2 Smooth eyelets on opposite sides | Slightly Different.
For CH10, CH12, CH14, and CH16 catheters, the eyelet’s tolerance has been changed from ±0.2 mm to ±0.3 mm in K252943. The slight dimensional tolerance change to eyelets at the tip of the catheter tubes would not change the device performance. |
| Tip Type | GentleCath Air for Men: Straight
GentleCath Glide Intermittent Catheter: Straight or Coudé
GentleCath Air for Women: Straight | Straight | Straight or Coudé | Straight | Same.
Each catheter tip type is equivalent to their predicate tip type. |
| Use Type | GentleCath Air for Men: Single Use
GentleCath Glide Intermittent Catheter: Single Use
GentleCath Air for Women: Single Use | Single Use | Single Use | Single Use | Same |

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K252943
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convatec
-- forever caring --

| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison |
| --- | --- | --- | --- | --- | --- |
| FeelClean Technology™ | GentleCath Air for Men: Yes.
GentleCath Glide Intermittent Catheter: Yes.
GentleCath Air for Women: Yes. | Yes | Yes | Yes | Same.
This submission includes additional claims regarding the FeelClean Technology™. |
| Sterilization | GentleCath Air for Men: X-Ray
SAL: 10^{-6}

GentleCath Glide Intermittent Catheter: X-Ray
SAL: 10^{-6}

GentleCath Air for Women: X-Ray
SAL: 10^{-6} | X-Ray
SAL: 10^{-6} | ETO
SAL: 10^{-6} | X-Ray
SAL: 10^{-6} | Different.
GentleCath Glide was sterilized using ETO previously in K181206, but it is changed to X-ray sterilization in K252943.

The change is to adopt the X-Ray method used for another device in the product family, GentleCath Air for Men (cleared in K213283) with a maximum sterilization dose of 44.3 kGy. |

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