GentleCath Glide Intermittent Catheter
Device Facts
| Record ID | K161344 |
|---|---|
| Device Name | GentleCath Glide Intermittent Catheter |
| Applicant | Convatec Limited |
| Product Code | KOD · Gastroenterology, Urology |
| Decision Date | Sep 20, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra. GentleCath intermittent catheters are intended for adult use only.
Device Story
Hydrophilic urological catheter; flexible tubular device for bladder drainage. Input: manual activation by user (squeezing water sachet to wet catheter surface). Principle: base material (Polyolefin Based Synthetic Thermoplastic Elastomer) contains hydrophilic additive; becomes slippery when wetted. Output: urine drainage via catheter tube. Used in clinical or home settings; operated by patient or clinician. Healthcare provider uses device to facilitate bladder emptying in patients unable to void naturally. Benefits: reduced friction during insertion; transient drainage of bladder.
Clinical Evidence
Bench testing only. Comparison tests performed: flow rate, catheter tensile properties, and coefficient of friction. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), skin irritation (ISO 10993-10), genotoxicity (ISO 10993-3), subchronic toxicity (ISO 10993-11), and EtO residuals (ISO 10993-7). Results indicate performance is similar or superior to predicate devices.
Technological Characteristics
Materials: Polyolefin Based Synthetic Thermoplastic Elastomer (POBE) base, PVC/DEHT connector. Hydrophilic surface achieved via integrated additive. Dimensions: Male 405mm, Female 150-200mm; CH10-CH16 sizes. Connectivity: None. Sterilization: Ethylene Oxide (EO). Design: Nelaton tip, staggered eyelets, no-touch sleeve.
Indications for Use
Indicated for routine transient intermittent drainage of the bladder in adult patients via urethral insertion.
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
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
ConvaTec Limited Elinor Jones Regulatory Affairs Specialist GDC, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom
Re: K161344 Trade/Device Name: GentleCath Glide Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 10, 2016 Received: August 22, 2016
Dear Elinor Jones:
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 (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. 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.
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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
# Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K161344
Device Name
GentleCath Glide Intermittent Catheter
Indications for Use (Describe)
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
GentleCath Glide intermittent catheter is intended for adult use only.
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)
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Section 5 510(k) Summary
Applicant: ConvaTec Limited. Applicant Address: GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK The Establishment Registration number is 1000317571
- Contact: Elinor Jones Regulatory Affairs Specialist ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Tel: +44(0) 1244584176
Date Prepared: 10 May 2016
Device Identification:
Trade Name: GentleCath Glide Intermittent Urinary Catheter.
Common Name: Catheter, urethral
Regulation Number: 21 CFR §876.5130
Classification Panel: Gastroenterology and Urology
Classification Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: GBM
Product Reference: 421565, 421566,421567, 421568, 421571, 421572, 421574
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Predicate Devices: 510(K) number: K000070 Rüsch FloCath Quick
510(k) number: K050874 LoFric Primo
## Device Description
A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water.
## Intended Use
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra.
GentleCath intermittent catheters are intended for adult use only.
# Performance Testing - Bench
Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission. The Following comparison tests were performed to demonstrate equivalence:
- 1) Flow Rate
- 2) Catheter Tensile properties
- 3) Coefficient of Friction
The laboratory testing shows no differences that would indicate the GentleCath Glide Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter. Therefore the testing has demonstrated substantial equivalence of the GentleCath Glide intermittent Urinary Catheter to predicate devices.
# Substantial Equivalence Conclusion
It has been demonstrated through comparison of design features and performance testing, that the proposed device and its predicates have been found to be substantially equivalent; see following pages.
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#### Substantial Equivalence Discussion
The following table compares the similarities and differences between the subject GentleCath Glide Low Friction Intermittent Urinary Catheter and the predicates Rüsch Quick (ref; K00070) and LoFric Primo (ref; K050874, determined substantially equivalent on May 5 2005) and outlines the product characteristic's and specifications which form the basis of the substantial equivalence discussion.
The intended use, technological characteristics and principles of operation of the GentleCath Glide Low Friction intermittent urinary catheter remains the same as those of the predicate devices.
| | Subject Device | | | Comparison | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| FDA Product<br>Code | GBM | KOD | GBM | GentleCath Glide and<br>FloCath Quick have been<br>classified as urological<br>catheters. | Lo-Fric Primo has been<br>classified as a urethral<br>catheter. |
| FDA<br>Classification<br>Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are the same | None |
| Regulatory<br>Class | Class II | Class II | Class II | All devices are the same | None |
| Device<br>description | A hydrophilic urinary catheter<br>is a flexible tubular device that<br>is inserted through the urethra<br>and used to pass fluids from<br>the bladder. It includes a<br>substance that makes the<br>surface slippery when it<br>comes into contact w ith water.<br>The catheter is provided<br>together w ith a sterile w ater<br>sachet for lubrication | The Rüsch FloCath catheter<br>consists of a tubular PVC shaft<br>w ith attached drainage funnel.<br>The catheter is designed w ith a<br>Nelaton, Olive or Tiemann tip.<br>There are tw o drainage eyes in<br>various configurations (straight<br>through, staggered, vertical<br>orientated). This device shaft<br>may be uncoated or Hydrogel /<br>Hydrophilic coated. The coating<br>has been tested for both its<br>safety and function. | The LoFric Primo Single Use<br>Urinary Catheter is designed as an<br>intermittent pathw ay for drainage of<br>the bladder. The device consists of<br>a catheter, coated w ith a<br>hydrophilic low -friction coating.<br>The surface is hydrophilic and<br>w hen the catheter is activated w ith<br>the w ater integrated in the<br>package, it becomes slippery and<br>ready to use.<br>The catheter is provided in a<br>variety of lengths and sizes.<br>The catheter and the activation<br>w ater is separated, sealed in one<br>bag.<br>By holding the product upright and<br>exerting a light pressure on the<br>folded w ater pocket, the w ater w ill | All devices are developed<br>around the same basic<br>design of a tube w ith a<br>funnel and tw o drainage<br>eyes. With surface<br>properties that become<br>hydrophilic w hen wet. | GentleCath Glide contains<br>an additive w ithin the<br>base material w hile both<br>FloCath Quick and Lo-Fric<br>Primo have a coating. |
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| | | | run dow n and w et the catheter. The<br>bag is opened and the catheter is<br>inserted into the patient's urethra | | | |
|--|--|--|------------------------------------------------------------------------------------------------------------------|--|--|--|
|--|--|--|------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Subject Device | | | Comparison | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| Intended use /<br>Indication for<br>Use | Intermittent catheters are<br>indicated for routine transient<br>drainage of the bladder. The<br>catheter is inserted through<br>the urethra.<br>For adult use only. | Rüsch FloCath catheter is<br>flexible tubular device that is<br>inserted through the urethra and<br>is used to pass fluids to or from<br>urinary tracts | The LoFric Primo Single Use<br>Urinary Catheter is intended for<br>intermittent catheterization of the<br>urethra | All devices are intended<br>for bladder catheterization<br>through the urethra | GentleCath does not<br>include the intended use<br>of administration of fluids<br>to the bladder, unlike<br>FloCath does |
| Cautions | Single use<br>Prescription only | Single use<br>Prescription only | Single use<br>Prescription only | All devices are the same | None |
| Tube Material | POBE | DEHP-free PVC | POBE | The base material of<br>GentleCath Glide is the<br>same as LoFric Primo | FloCath Quick has a<br>different base material to<br>GentleCath Glide and<br>LoFric Primo |
| Coating/<br>additive | Additive within the base<br>material | PVP (polyvinyl pyrrolidone) | PVP (polyvinyl pyrrolidone) and<br>sodium chloride | All three devices have<br>surface properties that<br>become hydrophilic and<br>slippery when wet. | The addition of theadditive is a different way<br>of achieving a hydrophilic<br>surface from the PVP<br>coating. Biocompatibility<br>studies of the device<br>conclude that the material<br>compound is safe for the<br>intended use. |
| Connector<br>Material | PVC + DEHT | DEHP-free PVC | POBE | All three connectors are<br>similar in design. | The exact material<br>composition of competitor<br>products is unknown to<br>ConvaTec However,<br>GentleCath Glide funnel is<br>exactly the same as<br>marketed GentleCath<br>male Olive tip K140953 |
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| Glue for<br>assembly | Loctite | Not known | Loctite | The glue used to produce<br>LoFric Primo and<br>GentleCath Glide<br>products is exactly the<br>same. | The assembly method<br>used for FloCath Quick is<br>not known to ConvaTec |
|----------------------|---------|-----------|---------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
|----------------------|---------|-----------|---------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Subject Device | | | Comparison | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Parameter | GentleCath Glide Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| Biocompatibility | Evaluation and testing within<br>risk management process<br>ISO 10993-1<br>Cytotoxicity ISO 10993-5<br>Sensitization ISO10993-10<br>Skin Irritation ISO10993-10<br>Genotoxicity ISO10993-3<br>Subchronic Toxicity ISO<br>10993-11<br>EtO sterilization residuals<br>ISO 10993-7 | Not known | Not known | The exact biocompatibility<br>tests performed on<br>FloCath Quick and LoFric<br>Primo are not known to<br>Convatec.<br>GentleCath Glide is tested<br>in compliance with ISO<br>10993-1:2009 for surface<br>devices in contact with<br>mucosal membrane for a<br>limited time period.<br>Genotoxicity and<br>subchronic toxicity are<br>also included due to the<br>prolonged use some<br>patients may be exposed<br>to overtime.<br>Biocompatibility studies of<br>the device conclude that<br>the material compound is<br>safe for the intended use | Not Known |
| Principal of<br>operation - short<br>description of<br>use | Squeeze water pocket<br>Peel pack open<br>Insert catheter | Squeeze water pocket<br>Hang and let soak for 30sec<br>Peel pack open<br>Insert catheter | Unfold pack<br>Squeeze water pocket<br>Hang and let soak for 30sec<br>Peel pack open<br>Insert catheter | Principal of operation is<br>similar for all three<br>devices | GentleCath Glide does not<br>require soaking before use |
| | Empty bladder | Empty bladder | Empty bladder | | |
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| | Withdraw catheter<br>Dispose device | Withdraw catheter<br>Dispose device | Withdraw catheter<br>Dispose device | | |
|----------------|-------------------------------------|--------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Length<br>(mm) | Male: 405mm<br>Female: 150-200mm | Male: 400mm<br>Female: 200mm<br>Pediatric: 300mm | Male: 400mm<br>Female: 200mm / 150mm<br>Pediatric: 200mm | Catheter lengths all<br>comply w ith the<br>requirements of<br>EN1616:1997 Sterile<br>Urethral Catheters for<br>Single Use, Table 1. Shaft<br>dimensions | Some differences in length<br>betw een the products, but<br>all in compliance w ith<br>EN1616:1997 Sterile<br>Urethral Catheters for<br>Single Use, Table 1. Shaft<br>dimensions. |
| | Subject Device | | | Comparison | |
|-------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| FR Size | Male: CH10-CH16<br>Female: CH10-CH16 | Male: CH08-CH20<br>Female: CH08-CH20<br>Pediatric: CH06-CH10 | Male: CH08-CH18<br>Female: CH08-CH18<br>Pediatric: CH06-CH10 | All sizes of GentleCath<br>Glide are included w ithin<br>the ranges of the<br>predicate devices | Predicate devices have a<br>bigger size range.<br>GentleCath Glide is being<br>initially launched w ith a<br>smaller size range. |
| Connector color<br>indicating size | CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange | CH06: green<br>CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red<br>CH20: Yellow | CH06: green<br>CH08: Blue<br>CH10: Black<br>CH12: White<br>CH14: Green<br>CH16: Orange<br>CH18: Red | Connector colour coding<br>all comply w ith ISO<br>8836:2007 Suction<br>catheters for use in the<br>respiratory tract : Table 1 | None |
| Catheter tube -<br>outer diameter<br>(mm) | CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33 | CH06: 2.00<br>CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33 | CH06: 2.00<br>CH08: 2.67<br>CH10: 3.33<br>CH12: 4.00<br>CH14: 4.67<br>CH16: 5.33 | Catheter outer diameters<br>all comply w ith the<br>requirements of<br>EN1616:1997 Sterile<br>Urethral Catheters for<br>Single Use, Table 2. | Predicate devices have a<br>bigger size range.<br>GentleCath Glide is being<br>initially launched w ith a<br>smaller size range. |
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| | | CH18: 6.00 | CH18: 6.00 | | |
|-----------------|---------------|-------------------------------------------------------------------------------|----------------------|---------------------------------------------|------|
| Eyelets | Smooth eyelet | Gently rounded catheter eyes<br>which are<br>vertically cut and heat polished | Smooth catheter eyes | All three eyelets are<br>similar in design. | None |
| Eyelet position | Staggered | Staggered | Staggered | All three eyelets are<br>similar in design. | None |
| | Subject Device | | | Comparison | |
|---------------------------|---------------------------------------|----------------------------------------------|------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Parameter | GentleCath Glide Catheter | Predicate 1<br>Teleflex: Rüsch FloCath Quick | Predicate 2<br>Wellspect: Lo-Fric Primo | Similarities | Differences |
| Tip types in<br>range | Nelaton | Nelaton<br>Tiemann/Coude | Nelaton<br>Tiemann/Coude | All three product ranges<br>include the same tip<br>shapes | Predicate devices also<br>have a range of<br>tiemenn/Coude tip shapes |
| No-touch<br>functionality | Sleeve | Sleeve | Sleeve | GentleCath Glide is<br>similar to FloCath Quick | LoFric primo is different in<br>that the sleeve is part of<br>the packaging and not a<br>standalone accessory |
| Liquid for<br>wetting | Sterile water | 0.9% Sterile saline solution | Sterile water | GentleCath Glide is<br>similar to LoFric Primo | GentleCath Glide is<br>different from FloCath<br>Quick |
| Sticky-dot | Double sided adhesive dot | Double sided adhesive dot | Glue blob | GentleCath Glide is<br>similar to FloCath Quick | LoFric Primo is different in<br>that the sticky dot is a glue<br>dot. |
| Primary<br>packaging | Paper and film peel pack | Paper and film peel pack | Polyethylene with a<br>PET/PE/Aluminium water sachet | GentleCath Glide is<br>similar to FloCath Quick | LoFric Primo is different in<br>that its primary packaging is<br>made frompolyethylene. |
| Secondary<br>packaging | Corrugated board, Box<br>quantity: 30 | Corrugated board, Box quantity:<br>30 | Corrugated board, Box quantity:<br>30 | All three product are<br>packed in similar boxes | None |
| Shipper case | Corrugated board | Corrugated board | Corrugated board | All three product are<br>packed in similar shipper | None |
| Sterilization<br>process | EO | EO | Radiation | GentleCath is similar to<br>FloCath quick | LoFric primo uses a<br>different sterilization<br>method. |
| Shelf life | 18 months | 5 years | Unable to obtain | | GentleCath Glide has a |
| | | | | | shorter shelf life which will |
| | | | | | be extended as real-time |
| | | | | | and additional accelerated |
| | | | | | stability information |
| | | | | | becomes available to |
| | | | | | support. |
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