Durex Penck III Regular
Device Facts
| Record ID | K222068 |
|---|---|
| Device Name | Durex Penck III Regular |
| Applicant | Rb Health (Us), LLC |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Oct 12, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Device Story
Durex Penck III Regular is a natural rubber latex condom designed for OTC use. It features a taper-shaft, teat-ended, smooth-surface design. The device is provided with silicone lubricant (400 mg or 480 mg for Extra Lubricant variety). It is packaged in flexible laminate foils (PET, polyethylene, aluminum) within a cardboard carton. The condom acts as a physical barrier to prevent the exchange of bodily fluids during sexual intercourse, thereby providing contraception and reducing STI transmission risk. It is a non-sterile, single-use device.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) per ISO 10993 standards confirmed the device is non-irritating, non-sensitizing, and non-toxic. Physical performance testing confirmed compliance with ISO 4074:2015 and ASTM D3492-16. Accelerated stability testing supports a 5-year shelf life.
Technological Characteristics
Material: Natural rubber latex. Lubricant: Silicone. Dimensions: 195 mm length, 56 mm width, 48 um thickness. Standards: ASTM D3492-16, ISO 4074:2015. Biocompatibility: ISO 10993-5, -10, -11. Packaging: PET/polyethylene/aluminum laminate foil. Non-sterile.
Indications for Use
Indicated for contraception and reduction of risk of pregnancy and STIs in individuals using male condoms.
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
Predicate Devices
- Durex Penck Standard, Durex Penck X (K200672)
Submission Summary (Full Text)
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October 12, 2022
RB Health (US) LLC Kyle Prince Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054
Re: K222068
Trade/Device Name: Durex Penck III Regular Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: July 13, 2022 Received: July 14, 2022
Dear Kyle Prince:
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. 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 located 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, 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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# Indications for Use
510(k) Number (if known) K222068
Device Name Durex Penck III Regular
Indications for Use (Describe)
The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summarv K222068 Durex Penck III Regular
## 1. Submitter Information
| Applicant: | RB Health (US) LLC |
|------------|---------------------------------------------------|
| Address: | 399 Interpace Parkway Parsippany<br>NJ 07054-0024 |
| Phone: | (862) 325-0012 |
## 2. Correspondent Information
| Company: | RB Health (US) LLC |
|----------|-------------------------|
| Contact: | Kyle Prince |
| Phone: | (862) 325-0012 |
| Email: | kyle.prince@reckitt.com |
#### 3. Date prepared: October 7, 2022
#### 4. Device Information
| Device Name: | Durex Penck III Regular |
|--------------------|----------------------------------|
| Common Name: | Male Natural Rubber Latex Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | HIS (Condom) |
| Regulatory Class: | Class II |
#### 5. Predicate Device Information
| Device Name: | Durex Penck Standard, Durex Penck X |
|----------------|-------------------------------------|
| 510(k) Number: | K200672 |
| Sponsor: | RB Health (US) LLC |
| Manufacturer: | Reckitt Benckiser LLC |
The predicate device has not been subject to a design-related recall.
# 6. Device Description
Durex Penck III Regular are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Penck III Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Penck III Regular have a nominal length of 195 mm, width of 56 mm, and thickness of 48 um and are provided in Regular and Extra Lubricant varieties with 400 mg and 480 mg silicone lubricant respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Penck III Regular condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
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Device specifications are listed in Table 1 below.
# 7. Indications for Use Statement
The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
# 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| | Subject Device<br>Durex Penck III Regular<br>K222068 | Predicate Device<br>Durex Penck Standard,<br>Durex Penck XL<br>K200672 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device & Predicate Device | Durex Penck III Regular | Durex Penck Standard<br>Durex Penck XL |
| 510(K) Number | K222068 | K200672 |
| Product Code | HIS | HIS |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The Durex Penck III Regular<br>condom is used for<br>contraception and for<br>prophylactic purposes (to<br>help reduce the risk of<br>pregnancy and the<br>transmission of sexually<br>transmitted infections, STIs). | The Durex Penck Standard<br>Condom is used for<br>contraception and for<br>prophylactic purposes (to<br>help reduce the risk of<br>pregnancy and the<br>transmission of sexually<br>transmitted infections, STIs).<br>The Durex Penck XL<br>Condom is used for<br>contraception and for<br>prophylactic purposes (to<br>help reduce the risk of<br>pregnancy and the<br>transmission of sexually<br>transmitted infections, STIs). |
| Prescription or Over-The-<br>Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex |
| Width | Nominal: $56 \pm 2$ mm<br>Mid Body: $54 \pm 2$ mm | Durex Penck Standard: $54 \pm 2$ mm<br>Durex Penck XL: $57 \pm 2$ mm |
| Nominal Length | $195 \pm 10$ mm | $190 \pm 10$ mm |
| Nominal Thickness | $0.048 \pm 0.008$ mm | Durex Penck Standard: 0.048 mm |
Table 1. Comparison of Intended Use and Technological Characteristics
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| | | - 0.002 mm |
|--------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | | Durex Penck XL:0.050 +<br>0.004 /<br>- 0.002 mm |
| Lubricant | Silicone | Silicone |
| Lubricant Quantity | Durex Penck III Regular:<br>400 ± 50 mg<br>Durex Penck III Regular<br>Extra Lubricant:<br>480 ± 50 mg | Durex Penck Standard: 400 ±<br>50 mg<br>Durex Penck XL: 480 ± 50<br>mg |
| Air Burst Pressure | > 1.0 kPa | > 1.0 kPa |
| Air Burst Volume | 18.0 L | Durex Penck Standard:<br>Minimum 18.0 L<br>Durex Penck XL: Minimum<br>22.0 L |
| Sterilization | Non-Sterile | Non-sterile |
| Texture | Taper shaft, teat ended<br>smooth condom | Smooth, straight walled, and<br>teat ended |
| Shelf Life | 5 Years | 5 Years |
| Color Additives | N/A | N/A |
| Flavor Additives | N/A | N/A |
The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based, are lubricated with silicone, and have the same shelf-life duration. The subject and predicate devices do have different technological characteristics, including different dimensions and specifications (e.g., burst volume). However, the different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.
# 9. Summary of Non-Clinical Performance Testing
# Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- · Cytotoxicity (ISO 10993-5:2009/R 2014)
- · Sensitization (ISO 10993-10:2010/R 2014)
- · Vaginal Irritation (ISO 10993-10:2010/R 2014)
- · Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
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### Physical Performance Testing:
The Durex Penck III Regular was tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).
### Shelf Life:
The Durex Penck III Regular has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
#### 10. Conclusion
The results of the performance testing described above demonstrate that the Durex Penck III Regular is as safe and effective as the predicate device and supports a determination of substantial equivalence.
