JO Coconut Hybrid Cooling Personal Lubricant

K232091 · CC Wellness, LLC · NUC · Oct 22, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K232091
• Device Name: JO Coconut Hybrid Cooling Personal Lubricant
• Applicant: CC Wellness, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Oct 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO Coconut Hybrid Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Personal lubricant for penile, anal, and/or vaginal application; intended to lubricate, moisturize, and enhance comfort during sexual activity. OTC product; supplied in 1 fl. oz. and 4 fl. oz. PET bottles. Applied topically by the user. Formulation includes water, coconut oil, shea butter, and cooling agents (menthyl lactate, etc.). Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Benefits include supplementation of natural lubrication and increased comfort.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) confirmed non-toxic and non-irritating. Condom compatibility tested per ASTM D7661-18. Shelf-life validated via real-time aging study (3 years). Antimicrobial effectiveness per USP <51> and microbial limits per USP <61>/<1111> met.

Technological Characteristics

Non-sterile, water-based, viscous liquid. Ingredients: Water, Propylene Glycol, Caprylic/Capric Triglyceride, Coconut Oil, Shea Butter, cooling agents, and various stabilizers. Viscosity: 20,000–30,000 cps (USP <911>); pH: 5.50–6.50 (USP <971>); Osmolality: 775–950 mOsm/kg (USP <785>). Packaging: PET bottles. Testing standards: ASTM D7661-18 (condom compatibility), ISO 10993 (biocompatibility), USP <51>, <61>, <62>, <841>, <911>, <971>.

Indications for Use

Indicated for individuals requiring lubrication and moisturization for penile, anal, and/or vaginal application to enhance comfort during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use 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

• Coconut Infused Hybrid Personal Lubricant (K180712)

Submission Summary (Full Text)

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October 22, 2023

CC Wellness LLC Marlent Perez Regulatory Affairs Specialist II 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K232091

> Trade/Device Name: JO Coconut Hybrid Cooling Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 17, 2023 Received: July 25, 2023

Dear Marlent Perez:

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.

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 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-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 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.

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 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)

#### K232091

Device Name JO Coconut Hybrid Cooling Personal Lubricant

Indications for Use (Describe)

JO Coconut Hybrid Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

| Type of Use (Select one or both, as applicable) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span style="text-decoration:line-through">☐</span> Pre-clinical Use (21 CFR 361.1 Subpart B)</td><td><span style="text-decoration:line-through">☑</span> Over-The-Counter Use (21 CFR 361.1 Subpart C)</td></tr></table> | <span style="text-decoration:line-through">☐</span> Pre-clinical Use (21 CFR 361.1 Subpart B) | <span style="text-decoration:line-through">☑</span> Over-The-Counter Use (21 CFR 361.1 Subpart C) |
| <span style="text-decoration:line-through">☐</span> Pre-clinical Use (21 CFR 361.1 Subpart B) | <span style="text-decoration:line-through">☑</span> Over-The-Counter Use (21 CFR 361.1 Subpart C) | |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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CC
WELLNESS

JO Coconut Hybrid Cooling Personal Lubricant

# 510(k) Summary K232091

CC Wellness LLC 510(k) Owner:

Street Address: 29000 N. Hancock Parkway Valencia, CA 91355

> Marlent Perez Regulatory Affairs Specialist II

> > Bruce Albert Chief Scientific Officer

Contact Numbers:

Contact Person:

Phone: [phone] Phone: [phone]

Summary Preparation Date:

October 10, 2023

### Subject Device Information:

| Trade Name: | JO Coconut Hybrid Cooling Personal Lubricant |
|--------------------|----------------------------------------------|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |

#### Predicate Device Information:

| Product Name: | Coconut Infused Hybrid Personal Lubricant |
|-----------------|-------------------------------------------|
| 510 (k) number: | K180712 |
| Manufacturer: | United Consortium |
| Product Code: | NUC (lubricant, personal) Class |
| Device Class: | II |

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

#### Device Description:

JO Coconut Hybrid Cooling Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

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Image /page/4/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". Below the letters, the word "WELLNESS" is written in a simple, sans-serif font. The overall design is minimalist and elegant, with a focus on the flowing lines of the cursive letters.

JO Coconut Hybrid Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL bottle. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Polyisobutene, Polysorbate 20, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Beeswax Glyceryl Stearate, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, PEG45M, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin and Polyquaternium-67.

The device specifications are listed in the table below:

| Property | Specification |
|--------------------------------------------------------------|-------------------------------------------------------------|
| Appearance | Viscous opaque liquid |
| Color | Opaque, off-white |
| Odor | Mild Coconut |
| Viscosity (cps) per USP <911> | 20,000 – 30,000 |
| pH per USP <971> | 5.50 – 6.50 |
| Specific Gravity per USP <841> | 0.980 – 1.050 |
| Osmolality per USP <785> | 775 - 950 mOsm/kg (1:1 dilution) |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2 products. |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |

#### Table 1: Device Specifications for JO Coconut Hybrid Cooling Personal Lubricant

## Indications for Use:

JO Coconut Hybrid Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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Comparison of Intended Use and Technological Characteristics with Predicate Device:

The table below lists the comparative intended use and technological characteristics of the subject and predicate device.

| Feature | JO Coconut Hybrid Cooling<br>Personal Lubricant | Coconut Infused Hybrid Personal<br>Lubricant (K180712) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Coconut Hybrid Cooling<br>Personal Lubricant is a personal<br>lubricant for penile, anal and/or<br>vaginal application, intended to<br>lubricate and moisturize, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene condoms.<br>This product is not compatible<br>with polyurethane condoms. | Coconut Infused Hybrid Personal<br>Lubricant is a personal lubricant for<br>penile, anal and/or vaginal<br>application, intended to lubricate<br>and moisturize, to enhance the<br>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. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,<br>Caprylic/Capric Triglyceride,<br>Cocos Nucifera (Coconut) Oil,<br>Flavor (Aroma), Phenoxyethanol,<br>Polyacrylate 13, Cellulose Gum,<br>Raphanus Sativus (Radish) Seed<br>Extract, Polyisobutene, Polysorbate<br>20, Butyrospermum Parkii (Shea)<br>Butter Extract, Ethyl Menthane<br>Carboxamide, Methyl Diisopropyl<br>Propionamide, Beeswax Glyceryl<br>Stearate, Menthyl Lactate, PEG-100<br>Stearate, Stearamidopropyl<br>Dimethylamine Lactate, PEG45M,<br>Caprylyl Glycol, Phenethyl Alcohol,<br>Ethylhexylglycerin, Polyquaternium-<br>67. | Water (Aqua), Propylene Glycol,<br>Caprylic/Capric Triglyceride, Cocos<br>Nucifera (Coconut) Oil, Flavor<br>(Aroma), Phenoxyethanol,<br>Polyacrylate 13, Cellulose Gum,<br>Raphanus Sativus (Radish) Seed<br>Extract, Polyisobutene,<br>Polysorbate 20, PEG-45M |
| pH | 5.50 - 6.50 | 5.30 - 6.30 |
| Osmolarity | 775 - 950 mOsm/kg (1:1 dilution) | 300 - 950 mOsm/kg |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex and<br>Polyisoprene | Natural Rubber Latex and<br>Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |

# Table 2: Comparator Table for Subject Device – JO Coconut Hybrid Cooling Personal Lubricant and Predicate Device – Coconut Infused Hybrid Personal Lubricant

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The subject and predicate device have the same indications for use and intended use. The subject and predicate devices have different technological characteristics including different formulations and device specifications. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

# Summary of Non-Clinical Performance Data:

# Biocompatibility

Biocompatibility testing was 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" as follows:

- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.

# Shelf-Life:

The subject device is a non-sterile personal lubricant with a 3-year shelf-life in accordance with the results of a real time aging study. Results from this testing demonstrated that the device maintains its specifications as shown in Table 1 over the duration of its shelf life.

# Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this testing demonstrated JO Coconut Hybrid Cooling Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

# Conclusion:

The results of the performance testing described above demonstrate that JO Coconut Hybrid Cooling Personal Lubricant is safe and effective as the predicate device and supports a determination of substantial equivalence.