OFNat Lubricant (L15)

K221243 · Suretex Limited · NUC · Sep 30, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K221243
• Device Name: OFNat Lubricant (L15)
• Applicant: Suretex Limited
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

OFNat Lubricant (L15) is a personal lubricant for vaginal and penile application, intended to moisturize and lubricate, 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

OFNat Lubricant (L15) is a water-based personal lubricant; applied topically to vaginal or penile areas to moisturize and reduce friction during sexual activity. Sold as an over-the-counter (OTC) product in 80 ml HDPE bottles or 5 ml sachets. Formulation includes water, propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum. Device provides physical lubrication; enhances comfort; supplements natural body fluids. Users apply manually as needed. Compatibility testing confirms safety with natural rubber latex and polyisoprene condoms; incompatibility with polyurethane condoms noted. Benefits include improved sexual comfort and reduced irritation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). Condom compatibility tested per ASTM D7661-10(R) 2017. Accelerated aging studies support a 17-month shelf-life. Microbial and antimicrobial effectiveness testing performed per USP <61>, <62>, and <51>.

Technological Characteristics

Water-based personal lubricant. Ingredients: water, propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, flaxseed gum. Viscosity: 2,200–3,500 cps (USP <911>); pH: 3.8–4.5 (USP <791>); Osmolality: 3,100–4,100 mOsm/kg (USP <785>). Non-sterile. Packaged in HDPE bottles or sachets. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661-10(R) 2017.

Indications for Use

Indicated for adults requiring vaginal or penile lubrication to enhance comfort during 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

• Lifestyles Natural Personal Lubricant (K122054)

Submission Summary (Full Text)

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September 30, 2022

Suretex Limited % Carole C. Carey Senior Consultant C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759

Re: K221243 Trade/Device Name: OFNat Lubricant (L15) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 31, 2022 Received: September 1, 2022

Dear Carole C. Carey:

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 ([e-mail]) or phone [phone] 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) K221243

Device Name OFNat Lubricant (L15)

#### Indications for Use (Describe)

OFNat Lubricant (L15) is a personal lubricant for vaginal and penile application, intended to moisturize and lubricate, 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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# 510(k) Summary K221243 OFNat Lubricant (L15)

#### 1. Submitter Information

Applicant: Suretex Limited Contact: KC Nguyen, Vice President, R&D, QA and RA Address: 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin Suratthani 84130 Thailand Phone: [phone] Email: [e-mail]

#### 2. Correspondent Information

Correspondent firm: C3-Carey Consultants, LLC Contact: Carole Carey Address: 9451 Ellsworth Court, Fulton, MD 20759 USA Phone: [phone] Email: [e-mail]

#### 3. Date prepared: September 27, 2022

#### 4. Subject Device Information

Device Trade Name: OFNat Lubricant (L15) Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: Class II

#### 5. Predicate Device Information

Device Name: Lifestyles Natural Personal Lubricant 510(k) Number: K122054 Manufacturer: Ansell Healthcare Products LLC

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

#### 6. Device Description

OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.

Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum.

OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.

Device specifications for the OFNat Lubricant (L15) are listed in Table 1.

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| Property | Specification |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Semi-Viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (per USP<911>) | 2,200 – 3,500 cps |
| pH (per USP<791>) | 3.8 – 4.5 |
| Osmolality (per USP<785>) | 3,100 – 4,100 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g |
| Presence of Pathogens (per USP <62>) | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Salmonella spp. | Absent |
| Clostridia spp | Absent |
| Antimicrobial Effectiveness Testing (per USP <51>) | Specification |
| Bacteria | Meets USP <51> criteria for category 2.<br>No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days |

#### Table 1: Device Specifications for OFNat Lubricant (L15)

#### 7. Indications for Use

OFNat Lubricant (L15) is a personal lubricant for vaginal and penile application, intended to moisturize and lubricate, 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.

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

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

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### Table 2: Intended Use and Technological Characteristics Comparison of the Subject and Predicate Device

| | OFNat Lubricant (L15)<br>K221243<br>Subject Device | LifeStyles® Natural Personal<br>Lubricant<br>K122054<br>Predicate Device |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | OFNat Lubricant (L15) is a personal<br>lubricant for vaginal and penile<br>application, intended to moisturize and<br>lubricate, to enhance the ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is compatible<br>with natural rubber latex and<br>polyisoprene condoms. This product is<br>not compatible with polyurethane<br>condoms. | Lifestyles(r) natural personal lubricant<br>is a personal lubricant, for penile<br>and/or vaginal application, intended to<br>moisturize and lubricate, to 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, polyurethane, and<br>polyisoprene condoms. |
| Base type | Water | Water |
| Primary ingredients | Water (Aqua), Propanediol, Okra<br>Extract, Hydroxyethylcellulose, Sodium<br>Lactate, Benzoic Acid, Flaxseed Gum | Water (Aqua), Glycerin, Xanthan<br>Gum, Sodium Hyaluronate, Potassium<br>Sorbate, Sorbic Acid, Sodium<br>Chloride |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance | Semi-Viscous liquid | -- |
| Color | Clear | -- |
| Odor | Odorless | -- |
| Viscosity | 2,200 – 3,500 cps | -- |
| pH | 3.8 – 4.5 | -- |
| Osmolality | 3,100 – 4,100 mOsm/Kg | -- |
| Total Aerobic Microbial<br>count (TAMC) | <100 cfu/g | -- |
| Total Yeast and Mold Count<br>(TYMC) | <10 cfu/g | -- |
| Absence of Pathogenic<br>Organisms | Yes | Yes |
| Antimicrobial Effectiveness<br>Tested | Yes | Yes |
| Condom Compatibility | Compatible with natural rubber latex and<br>polyisoprene condoms | Compatible with natural rubber latex,<br>polyisoprene, and polyurethane<br>condoms |
| Biocompatibility Tested | Yes | Yes |
| Shelf life | 17 months | 36 months |

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The subject and predicate device indications for use and intended use are the same. The subject and predicate device have different technological characteristics, including formulations, shelf-life, and condom compatibility. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

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

#### 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." The following testing was conducted:

- 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 testing support the biocompatibility of the device materials.

#### Shelf-Life

The subject device has a shelf-life of 17 months. Results from accelerated aging demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

#### Condom Compatibility

The compatibility of OFNat Lubricant (L15) with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed OFNat Lubricant (L15) to be compatible with natural rubber latex and polyisoprene condoms. OFNat Lubricant (L15) is not compatible with polvurethane condoms.

#### 10. Conclusion

The results of the performance testing described above demonstrate that OFNat Lubricant (L15) is as safe and effective as the predicate device and supports a determination of substantial equivalence.