Water-soluble Personal Lubricant

K212104 · Foshan Pingchuang Medical Technology Co., Ltd. · NUC · Nov 18, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K212104
• Device Name: Water-soluble Personal Lubricant
• Applicant: Foshan Pingchuang Medical Technology Co., Ltd.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Nov 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Water-soluble Personal Lubricant is a personal lubricant for penile, anal and/or vaginal 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

Water-soluble Personal Lubricant is a non-sterile, water-based lubricant; intended for penile, anal, and vaginal application to moisturize and enhance comfort during sexual activity. Device is supplied in 250 mL polyethylene terephthalate bottles for over-the-counter use. Formulation includes water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Device is compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Clinical benefit is the supplementation of natural lubrication to facilitate intimate activity.

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. Shelf-life validated for 3 years via real-time testing. Microbial limits and antimicrobial effectiveness tested per USP <61> and USP <51>.

Technological Characteristics

Water-based lubricant; non-sterile. Ingredients: water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, sodium polyacrylate. Physical properties: semi-viscous liquid, clear, odorless. Viscosity: 3,000-5,000 mPa.s; pH: 5.0-6.0; osmolality: 700-850 mOsm/kg. Packaging: 250 mL polyethylene terephthalate bottles. Shelf life: 3 years.

Indications for Use

Indicated for individuals requiring penile, anal, or vaginal lubrication to enhance comfort during 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

• Agape Warming Personal Lubricant (K200208)

Submission Summary (Full Text)

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November 18, 2021

Foshan PingChuang Medical Technology Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China

Re: K212104

Trade/Device Name: Water-soluble Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 8, 2021 Received: October 18, 2021

Dear Joyce Yang:

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.

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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 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 (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,

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) K212104

Device Name Water-soluble Personal Lubricant

#### Indications for Use (Describe)

Water-soluble Personal Lubricant is a personal lubricant for penile, anal and/or vaginal 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 K212104 Water-soluble Personal Lubricant

# 1. Submitter Information

| Applicant: | Foshan PingChuang Medical Technology Co., Ltd |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Huang Zhiyue, |
| Address: | Room 301, No. 3, Huaye Road, Lingang<br>Pioneer Park, Shunjiang Neighborhood<br>Committee, Beijiao Town, Shunde District,<br>Foshan City, Guangdong 528312, China |
| Phone: | ([phone]) |

# 2. Correspondent Information

| Company: | Shenzhen Joyantech Consulting Co., Ltd. |
|----------|-----------------------------------------------------------------------------------|
| Contact: | Joyce Yang |
| Address: | 1713A, 17th floor, Block A, Zhongguan<br>Times Square, Nanshan District, Shenzhen |
| Phone: | ([phone]) |
| Email: | [e-mail] |

#### 3. Date prepared: November 18, 2021

# 4. Device Information

| Device Name: | Water-soluble Personal Lubricant |
|--------------------|----------------------------------|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |

# 5. Predicate Device Information

| Device Name: | Agape Warming Personal Lubricant |
|----------------|----------------------------------|
| 510(k) Number: | K200208 |
| Manufacturer: | CC Wellness LLC |

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

# 6. Device Description

Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.

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# K212104 Page 2 of 4

Device specifications are listed in Table 1 below.

| | Table 1: Device Specifications for Water-Soluble Personal Lubricant |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Property | Specification |
| Appearance | Semi-Viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity | 3,000 - 5,000 mPa.s |
| pH | 5.0 - 6.0 |
| Osmolality | 700 - 850 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per<br>USP <61>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, per<br>USP <61>) | <10 cfu/g |
| Presence of Pathogens (per USP <62>) | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Clostridia | Absent |
| Salmonella | Absent |
| Bile tolerant Gram-negative bacteria) | Absent |
| Antimicrobial Effectiveness Testing (per<br>USP <51>) | Specification |
| Bacteria | Meets USP <51> criteria for category 2.<br>No less than 2.0 log reduction from initial<br>count at 14 days and no increase from the 14-<br>day count at 28 days |
| Yeast and Molds | No increase from the initial calculated count at<br>14 and 28 days |

# 7. Indications for Use

Water-soluble Personal Lubricant is a personal lubricant for penile, anal and/or vaginal 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.

# Table 2: Comparator Table for Subject and Predicate Device

| | Water soluble Personal<br>Lubricant<br>K210104<br>Subject Device | Agape Warming Personal<br>Lubricant<br>K200208<br>Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Water-soluble Personal Lubricant is a<br>personal lubricant for penile, anal and/or vaginal application, intended to<br>moisturize and lubricate, to 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 and<br>polyisoprene condoms. This product is<br>not compatible with polyurethane<br>condoms. | Agape Warming Personal Lubricant is<br>a personal lubricant for penile, anal<br>and/or vaginal application, intended to<br>lubricant and moisturize, 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 and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms |
| Base type | Water | Water |
| Primary ingredients | Water, Propylene Glycol,<br>Hydroxyethyl Cellulose, Sodium<br>Hyaluronate, Potassium Sorbate, Citric<br>Acid, EDTA-2Na, Sodium Polyacrylate | Water, Propanediol,<br>Gluconolactone,<br>Hydroxyethylcellulose, Sodium<br>Benzoate, Polysorbate 20, Citric Acid<br>and Capsicum Oleoresin |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance | Semi-Viscous liquid | Semi-Viscous liquid |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 3,000-5,000 mPa.S | 2,150 - 4,000 mPa.S |
| pH | 5.0-6.0 | 3.4-4.5 |
| Osmolality | 700-850 mOsm/Kg | 575-750 mOsm/kg |
| Total Aerobic Microbial<br>count (TAMC) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count<br>(TYMC) | <10 CFU/g | <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>and polyisoprene condoms |
| Biocompatibility Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |

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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, viscosity, pH, and osmolality specifications. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

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# 9. Summary of Non-Clinical Performance Testing

# Biocompatibility

Biocompatibility studies were 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 3 years. Results from real-time 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 Water-soluble Personal Lubricant 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 Water-soluble Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Water-soluble Personal Lubricant not to be compatible with polyurethane condoms.

## 10. Conclusion

The results of the performance testing described above demonstrate that Water-soluble Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.