JO for Him H2O Gel Original Personal Lubricant

K192203 · United Consortium · NUC · Feb 10, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K192203
• Device Name: JO for Him H2O Gel Original Personal Lubricant
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO for Him H2O Gel Original 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

JO for Him H2O Gel Original Personal Lubricant is a clear, viscous, water-based personal lubricant. It is applied topically to penile, anal, or vaginal areas by the user to provide lubrication and moisture during intimate sexual activity. The device is sold over-the-counter in polyethylene tubes. It functions by providing a physical barrier and reducing friction. The user applies the gel manually as needed. The product benefits the patient by enhancing comfort and ease of sexual activity. It is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal/penile irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). Results showed the lubricant is non-irritating, non-sensitizing, and non-systemically toxic. Shelf-life validated via real-time aging study over 3 years. Condom compatibility tested per ASTM D7661-10, confirming compatibility with natural rubber latex and polyisoprene, but not polyurethane.

Technological Characteristics

Water-based gel containing Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Propylparaben, Hydroxyethylcellulose, and Sodium Hydroxide. Viscosity: 38,000-75,000 cps (USP <911>); pH: 5.25-7.50 (USP <971>); Specific Gravity: 0.980-1.200 (USP <841>); Osmolality: 600-900 mOsm/kg (USP <785>). Non-sterile. Packaged in polyethylene tubes with polypropylene flip tops. Tested for antimicrobial effectiveness per USP <51>.

Indications for Use

Indicated for individuals requiring lubrication for penile, anal, and/or vaginal application to enhance comfort during intimate sexual activity and supplement natural lubrication. 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

• Walgreens Personal Lubricating Jelly (K080978)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2020

United Consortium Marlent Perez Quality Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K192203

> Trade/Device Name: JO for Him H2O Gel Original Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 6, 2020 Received: January 8, 2020

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 (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

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Monica D. Garcia, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

Device Name

JO for Him H2O Gel Original Personal Lubricant

Indications for Use (Describe)

JO for Him H2O Gel Original 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)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in blue, with a gray element overlapping the top portion of the 'U'. The text "UNITED CONSORTIUM" is written in smaller, sans-serif font below the symbol.

| 510(k) Summary - K192203 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | United Consortium |
| Street Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 |
| Contact Person: | Marlent Perez<br>Quality Specialist |
| | Bruce Albert<br>Head of Technical Services |
| Contact Numbers: | Phone: [phone], ext. 1007<br>Phone: [phone], ext. 231<br>FAX: [phone] |
| Summary Preparation Date: | February 7, 2020 |
| Trade Name: | JO for Him H2O Gel Original Personal Lubricant |
| Common Name: | Personal Lubricant |
| Device Identification: | Regulation Name: Condom<br>Regulation Number: 21 CFR 884.5300<br>Product Code: NUC (lubricant, personal)<br>Regulatory Class: Class II |
| Predicate Device: | Product Name: Walgreens Personal Lubricating Jelly<br>510(k) Number: K080978<br>Manufacturer: Vast Resources<br>Product Code: NUC (lubricant, personal) |

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

Device Class:

### Device Description:

JO for Him H2O Gel Original Personal Lubricant is a clear/water white, 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 and supplement the body's natural lubrication.

Class II

This product is sold as an over-the-counter (OTC) product in 4 oz. and 8 oz. sizes provided in matte black, polyethylene (PE) tubes. These tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during

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Image /page/4/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" in blue, with a gray element above it that suggests a continuation of the "U" shape. Below the graphic is the text "UNITED CONSORTIUM" in a simple, sans-serif font, with "UNITED" stacked above "CONSORTIUM."

the production process.

This device is composed of Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Propylparaben, Hydroxyethylcellulose and Sodium Hydroxide.

The device specifications are listed in the table below:

| Property | Specification |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| Appearance | Clear, viscous liquid |
| Color | Clear, water white |
| Odor | Odorless |
| Viscosity (cps) per USP <911> | 38,000 cps to 75,000 cps |
| pH per USP <971> | 5.25 to 7.50 |
| Specific Gravity per USP <841> | 0.980 to 1.200 |
| Osmolality per USP <785> | 600 to 900 mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2<br>products. |
| Total aerobic microbial count (TAMC) per USP<br><61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP <61><br>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 for Him H2O Gel Original Personal Lubricant

### Indications for Use:

JO for Him H2O Gel Original 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.

### Predicate Device Comparison:

The table below lists the comparative indications for use and technological characteristics of the subject and predicate devices.

#### Table 2: Comparator Table for Subject Device – JO for Him H2O Gel Original Personal Lubricant and Predicate Device – Walgreens Personal Lubricating Jelly

| Feature | JO for Him H2O Gel Original<br>Personal Lubricant<br>(K192203) | Walgreens Personal Lubricating<br>Jelly (K080978) |
|----------------------------|----------------------------------------------------------------|---------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |

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Image /page/5/Picture/1 description: The image shows a logo with a stylized letter 'U' in blue and gray. The blue part of the 'U' is in the foreground, while the gray part is behind it, creating a three-dimensional effect. Below the 'U', the words 'UNITED CONSORTIUM' are written in a simple, sans-serif font. The overall design is clean and modern, suggesting a professional and unified organization.

| Indications for Use | JO for Him H2O Gel Original<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 with<br>polyurethane condoms. | Walgreens Personal Lubricating<br>Jelly is a personal lubricant, for<br>penile and/or vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the ease and<br>comfort of intimate sexual activity<br>and supplement the body's<br>natural lubrication. It can ease<br>insertion of rectal thermometers,<br>enemas and tampons. This<br>product is compatible with latex<br>condoms. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Water soluble | Yes | Yes |
| Ingredients | Water (Aqua), Acrylates/C10-30<br>Alkyl Acrylate Crosspolymer,<br>Glycerin, Methylparaben,<br>Propylparaben,<br>Hydroxyethylcellulose, Sodium<br>Hydroxide | Water, Glycerin,<br>Hydroxyethylcellulose, Sodium<br>Benzoate, Gluconolactone,<br>Chlorhexidine Digluconate,<br>Sodium Hydroxide |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Latex |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 2 years |

The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the primary intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations, condom compatibility and shelf-life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

### Summary of Performance Data:

### Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed 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 (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010) ●

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Image /page/6/Picture/1 description: The image features a logo with a stylized letter 'U' as its central element. The left side of the 'U' is colored in a deep blue, while the right side is in a light gray, creating a two-toned effect. Below the 'U', the words 'UNITED CONSORTIUM' are printed in a smaller font size, with 'UNITED' stacked above 'CONSORTIUM'. The overall design is clean and modern, suggesting a sense of unity and collaboration.

- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)

The results of this testing demonstrated that the subject lubricant is only slightly cytotoxic, non-irritating, , non-sensitizing and non-systemically toxic.

### Shelf-Life:

The subject device is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.

### Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that JO for Him H2O Gel Original 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 the JO for Him H2O Gel Original Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.