Joylux Intimacy Gel (PG3100)

K242958 · Joylux, Inc. · NUC · Mar 20, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K242958
• Device Name: Joylux Intimacy Gel (PG3100)
• Applicant: Joylux, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Joylux Intimacy Gel is a non-sterile, water-based personal lubricant. It is applied topically to the penis and/or vagina to provide lubrication and moisture during sexual activity. The gel is packaged in a 4oz/120mL 5-layer polyethylene tube. It is an over-the-counter product intended for consumer self-use. The device functions by providing a physical barrier/lubricant layer to reduce friction. It is not a contraceptive or spermicide. Healthcare providers do not operate the device; it is used by individuals to enhance comfort during intimate activity. The product is compatible with natural rubber latex and polyisoprene condoms but incompatible with polyurethane condoms.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). Shelf-life validated via real-time and accelerated aging (ASTM F1980-21). Condom compatibility tested per ASTM D7661-18. Microbial limits and antimicrobial effectiveness verified per USP <51>, <61>, and <62>.

Technological Characteristics

Water-based gel. Ingredients: Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra. Packaging: 5-layer polyethylene tube (70% LDPE, 30% HDPE). Specifications: pH 4.0-5.0, Viscosity 900-7800 cps, Osmolality 250-420 mOsm/kg. Non-sterile. Tested per USP <791>, <912>, <785>, <51>, <61>, <62>.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhance ease and comfort of intimate sexual activity, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane 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

• Bloomi Smooth Water Based Lubricant (K221328)

Submission Summary (Full Text)

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March 20, 2025

Joylux, Inc % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242958

Trade/Device Name: Joylux Intimacy Gel (PG3100) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: February 20, 2025

Dear Prithul Bom:

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.

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"

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(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-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 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 Rue"). 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-device-advicecomprehensive-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-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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -S

For

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) K242958

Device Name Joylux Intimacy Gel (PG3100)

### Indications for Use (Describe)

The Joylux Intimacy Gel is a water-based personal lubricant for vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms

| 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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### 510(k) Summary – K242948 Joylux Intimacy Gel (PG3100)

#### l. General Information on Submitter

| Applicant:<br>Address:<br>Telephone:<br>Contact Person:<br>Contact Title:<br>Email: | Joylux, Inc.<br>120 Lakeside Avenue, Suite<br>300, Seattle, WA 98122 USA<br>206-219-6444<br>Colette Courtion<br>CEO [e-mail] |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Information | |
| Contact Person: | Sarah Lacey Robbins<br>Quality Manager / Quality & Regulatory<br>Consultant, Rook Quality Systems,<br>1155 Mount Vernon Hwy, Suite 800<br>Dunwoody, GA 30338 |
| Phone: | 813-220-3686 |
| Email: | [e-mail] |
| Date Prepared: | March 19, 2025 |
| Device Information | |
| Trade Name: | Joylux Intimacy Gel (PG3100) |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number | 21 CFR 884.5300 |
| Device Class: | II |
| Product Code: | NUC (Lubricant, Personal) |

#### Predicate Device IV.

II.

III.

| Predicate Device | 510(k) Number |
|-------------------------------------|---------------|
| Bloomi Smooth Water Based Lubricant | K221328 |

The predicate device has not been subject to a design-related recall.

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#### V. Description of Device

Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.

The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.

The specifications for Joylux Intimacy Gel are described in Table 1.

| Parameter | Test<br>Method | Specification |
|---------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance/Color | Visual | Clear, colorless |
| Odor | Olfactory | Odorless |
| pH | USP<791> | 4.0-5.0 |
| Viscosity | USP<912> | 900-7800 |
| Osmolality | USP<785> | 250-420 mOsm/kg (1:10 dilution factor) |
| Antimicrobial Effectiveness | USP <51> | Meets USP <51> acceptance criteria for<br>Category 2 products. Bacteria: not less<br>than 2.0 log reduction from the initial<br>count at 14 days, and no increase from<br>14-days count at 28 days.<br>Yeasts and Molds: no increase from the<br>initial calculated count at 14 and 28<br>days. |
| Total Aerobic Microbial Count<br>(TAMC) | USP<61> | Less than 10 cfu/mL |
| Total Yeast and Mold Count<br>(TYMC) | USP<61> | Less than 10 cfu/mL |
| Absence of Pathogenic<br>Organisms (Candida<br>albicans, Pseudomonas<br>aeruginosa, Staphylococcus<br>aureus) | USP<62> | Absent |

# Table 1. Device Specifications

#### VI. Indications for Use

The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and

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### K242948 Page 3 of 5

comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

### VII. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The following table compares the intended use and technological characteristics of the subject and predicate device:

| Characteristic /<br>Feature | Joylux Intimacy Gel (subject<br>device) | Bloomi Smooth Water Based<br>Lubricant (predicate device) -<br>K221328 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for use | The Joylux Intimacy Gel is a water-<br>based personal lubricant for penile<br>and/or vaginal application, intended<br>to lubricate and moisturize, enhance<br>the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. This<br>product is compatible with natural<br>rubber latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | The Bloomi Smooth Water Based<br>Personal Lubricant is a water-based<br>personal lubricant for penile and/or<br>vaginal application, intended to<br>lubricate and moisturize, enhance the<br>ease and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber latex<br>and polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | The subject<br>and predicate<br>devices have<br>the same<br>intended use. |
| Water-Based<br>Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Ingredients | DI Water, Hydroxyethylcellulose,<br>Polyquaterium-5, Propylene Glycol,<br>PEG-45, Aloe Vera 200x Powder,<br>Sodium Hyaluronate, Geogard Ultra<br>(gluconolactone & sodium benzoate) | Water, Microcare SB, Microcare<br>SB, Hydroxyethylcellulose,<br>Cyamopsis Tetragonoloba<br>(Guar) Gum, Citric Acid,<br>Sodium Hyaluronate, Organic<br>Helianthus (Sunflower) Seed<br>Extract, Organic Camellia<br>Sinensis Leaf<br>(Green Tea) Extract. | Different |

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| Microbial Limits | TYMC <10 cfu/mL | TYMC <10 cfu/mL | Similar |
|-------------------------|----------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------|
| | TAMC <10 cfu/mL | TAMC <100 cfu/mL | |
| | | Absence of pathogenic organisms<br>testing | Absence of pathogenic organisms<br>testing |
| | | Antimicrobial effectiveness testing | Antimicrobial effectiveness testing |
| | | | |
| Viscosity | 900-7800 cps | 1800-4500 cps | Different |
| Osmolality | 250-420 mOsm/kg (1:10 dilution factor) | 110-140 mOsm/kg | Different |
| pH | 4.0-5.0 | 4.0-5.0 | Same |
| Condom<br>Compatibility | Compatible with natural rubber latex and polyisoprene condoms. | Compatible with natural rubber latex and polyisoprene condoms | Same |

The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different questions of safety and effectiveness.

#### VIII. Summary of Non-Clinical Performance Testing

### Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 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) ●
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) ●
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of the testing conducted support the biocompatibility of the subject device.

# Shelf Life

The subject device is a non-sterile personal lubricant packaged in polyethylene tubes

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K242948 Page 5 of 5

with a 24-month shelf-life in accordance with the results of real time and an accelerated aging study per ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

# Condom Compatibility

The subject device was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Joylux Intimacy Gel is compatible with natural rubber latex and polyisoprene condoms. Joylux Intimacy Gel is not compatible with polyurethane condoms.

#### IX. Conclusion

The results of the testing described above demonstrate that Joylux Intimacy Gel is as safe and effective as the predicate device and supports a determination of substantial equivalence.