GLISSANT Intimate Lubricant

K183050 · Vjuvenate, LLC · NUC · Jul 8, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K183050
• Device Name: GLISSANT Intimate Lubricant
• Applicant: Vjuvenate, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Story

GLISSANT Intimate Lubricant is a water-based, non-sterile, colorless, viscous personal lubricant; intended for OTC use to supplement natural lubrication during sexual activity. Device is packaged in a polyethylene bottle with a lockdown pump. It does not contain contraceptives or spermicides. Users apply the lubricant topically to the penis or vagina. The lubricant enhances comfort and ease of sexual activity. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device benefits patients by reducing friction and providing moisture during intimate activity.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, systemic toxicity, sensitization, vaginal irritation) showed non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic results. Condom compatibility confirmed per ASTM D7661-10. Shelf life of 12 months validated via accelerated aging (ASTM F1980-16) with successful testing of physical/chemical properties (pH, viscosity, osmolarity) and microbial limits (USP <51>, <61>, <62>).

Technological Characteristics

Water-based, non-sterile, viscous liquid. Ingredients include organic aloe barbadensis leaf juice, potassium sorbate, hydroxyethylcellulose, stevia, flavor. pH 3.9–4.1; viscosity 250–500 cps; osmolarity 160–222 mOsm/kg. Packaged in polyethylene bottle with lockdown pump. Tested per ASTM D7661-10 for condom compatibility and ASTM F1980-16 for shelf life. Microbial testing per USP <51>, <61>, <62>.

Indications for Use

Indicated for individuals requiring a personal lubricant for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity. Compatible with natural rubber latex, polyisoprene, and 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

• Aloe Cadabra® Personal Lubricant and Aloe Cadabra® Flavored/Scented Personal Lubricants (K124044)

Submission Summary (Full Text)

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July 8, 2019

Vjuvenate, LLC Karyn Eilber President. CEO 3435 Santa Monica Blvd. Suite 107 Santa Monica, CA 90405

Re: K183050 Trade/Device Name: GLISSANT Intimate Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 31, 2019 Received: June 7, 2019

#### Dear Karyn Eilber:

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. 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

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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-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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sharon Andrews Assistant Division 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) K183050

Device Name GLISSANT Intimate Lubricant

#### Indications for Use (Describe)

GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Type of Use (Select one or both, as applicable)

| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## K183050 - Traditional 510(k) Premarket Notification GLISSANT Intimate Lubricant

## GLISSANT Intimate Lubricant – K183050

## 510(k) Summary

| Submitter | VJUVENATE, LLC<br>3435 Ocean Park Boulevard, Suite 107<br>Santa Monica, CA 90405<br>[phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Karyn S. Eilber, MD<br>[e-mail]<br>[phone] Office<br>[phone] Mobile |
| Date prepared | July 5, 2019 |
| Device trade names | GLISSANT Intimate Lubricant<br>GLISSANT Intimate Lubricant - Fragrance Free<br>GLISSANT Intimate Lubricant - Sea Salt & Caramel |
| Device common name | Personal lubricant |
| Regulation number | 21 CFR 884.5300 |
| Regulation name | Condom |
| Regulatory class | Class II |
| Product code | NUC |
| Classification panel | Obstetrics/gynecology |
| Predicate device | Aloe CadabraⓇ Personal Lubricant and Aloe CadabraⓇ<br>Flavored/Scented Personal Lubricants (K124044)<br><br>The predicate device has not been subject to a design related recall. |
| Indications for use | GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel<br>is a personal lubricant, for penile and/or vaginal application,<br>intended to moisturize and lubricate, and to enhance the ease and<br>comfort of intimate sexual activity and supplement the body's<br>natural lubrication. This product is compatible with natural rubber<br>latex, polyisoprene, and polyurethane condoms. |
| Device description | GLISSANT Intimate Lubricant is a water-based, non-sterile,<br>colorless, viscous personal lubricant It does not contain a |
| | contraceptive or spermicidal component. The device is packaged in<br>a polyethylene bottle with a lockdown pump. The primary<br>packaging is plastic placed inside of a display box (dimensions<br>1.375" width x 1.375" depth x 4.75" height). |

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The device specifications are listed in the table below:

| Parameter | Specification acceptance<br>criteria |
|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Appearance | Clear, viscous |
| Color | Colorless |
| Odor | Odorless |
| pH | 3.9 – 4.1 |
| Specific gravity | 1.003 g/mL |
| Viscosity | 250 – 500 cps |
| Osmolarity | 160 – 222 mOsm/kg |
| Antimicrobial effectiveness | Per USP <51> (Category 2) |
| Total microbial count | Per USP <61> (<100 cfu/g) |
| Fungal/yeast/mold limits | Per USP <61> (<10 cfu/g) |
| Absence of pathogenic<br>organisms (e. coli, c.<br>salmonella sp., pseudomonas<br>aeruginosa, s. aureus,<br>clostridia sp., c. albicans) | Per USP <62> (absent) |

## SUBSTANTIAL EQUIVALENCE DISCUSSION

GLISSANT Intimate Lubricant has the same intended use when compared to the predicate device (Aloe Cadabra® Personal Lubricant and Aloe Cadabra® Flavored/Scented Personal Lubricants (K124044). The GLISSANT Intimate Lubricant has different technological characteristics compared to the predicate device; however, these differences do not raise different questions of safety or effectiveness. The following table compares GLISSANT™ Intimate Lubricant to the predicate device.

| | DEVICE | PREDICATE DEVICE |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GLISSANT | ALOE CADABRA® |
| Trade Name | Intimate Lubricant<br>Fragrance free and<br>Sea Salt & Caramel<br>(K183050) | Personal Lubricant and<br>Flavored/Scented<br>Lubricants<br>(K124044) |
| Regulation number | 21 CFR 884.5300 | |
| Regulation name | Condom | SAME |
| Regulatory class | Class II | |
| Product code | NUC | |
| Indications for use | GLISSANT Intimate<br>Lubricant Fragrance<br>Free/Sea Salt and Caramel | Aloe Cadabra®<br>Lubricant and Aloe<br>Cadabra® |
| | is a personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate,<br>and to enhance the ease<br>and comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible with<br>natural rubber latex,<br>polyisoprene, and<br>polyurethane condoms. | Flavored/Scented<br>Lubricants are personal<br>lubricants, for penile<br>and/or vaginal<br>application, intended to<br>moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible<br>with natural rubber latex<br>and polyisoprene<br>condoms. This product is<br>not compatible with<br>polyurethane condoms. |
| Device description | Water-based, non-sterile,<br>unscented and<br>flavored/scented personal<br>lubricant | Aloe-based, non-sterile,<br>flavored/scented<br>personal lubricant |
| Common ingredients | Organic aloe barbadensis<br>leaf juice, potassium<br>sorbate,<br>hydroxyethylcellulose,<br>stevia, flavor | Aloe |
| Biocompatibility tests<br>per ISO-10993 | Meets acceptance<br>requirements for all<br>biocompatibility tests | SAME |
| Condom compatibility<br>per ASTM D7661-10 | Compatible with natural<br>rubber latex, polyisoprene,<br>and polyurethane | Not compatible with<br>polyurethane condoms |
| Packaging | PETG plastic bottle with<br>lockdown pump packaged<br>in a carton | HDPE plastic bottle with<br>flip top cap packaged in<br>a carton |
| Shelf life | 1 year | 2 years |
| Stability tests per USP | Meets acceptance<br>requirements for microbial | SAME |

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# SUMMARY OFNON-CLINICAL PERFORMANCE DATA

# Biocompatibility

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The subject device was evaluated for biocompatibility in accordance with the 2016 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 per ISO 10993-5:2009
- Acute systemic toxicity per ISO 10993-11:2006
- Sensitization per ISO 10993-10:2010 ●
- Vaginal irritation per ISO 10993-10:2010

The results of this testing demonstrated that the subject lubricants are non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.

### Condom compatibility

Condom compatibility was performed according to the FDA recognized consensus standard ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that JO subject lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

### Shelf life (stability) testing

The shelf life of GLISSANT™ Intimate Lubricant is 12 months based on an accelerated aging study per ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

At baseline and following aging, the device met its specifications for appearance, color, odor, pH. specific gravity, viscosity, osmolarity, antimicrobial preservative effectiveness based on USP <51>, total aerobic microbial count and total yeast and mold count based on USP <61>, and absence of pathogenic organisms based on USP <62>.

### CONCLUSION

The results of the performance testing described above demonstrate that the GLISSANT Intimate Lubricants are as safe and effective as the predicate device and support a determination of substantial equivalence.