Personal Lubricant

{0}------------------------------------------------ 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. September 24, 2021 Shenzhen Huanqiu Xuebao Technology Co., Ltd. % Kevin Zhang General Manager Wenzhou ThiWe Business Consulting Co., Ltd. Room 1203, Building C, Hua'ou Jiayuan, No. 50 Tangjiaqiao South Road Longwan District, Wenzhou, Zhejiang 325000 China K210857 Re: Trade/Device Name: Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 25, 2021 Received: August 25, 2021 # Dear Kevin Zhang: 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. {1}------------------------------------------------ Page 2 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210857 Device Name Personal Lubricant Indications for Use (Describe) Personal Lubricant is a water based personal lubricant, for penile 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K210857 Personal Lubricant #### 1. Submitter Information | Applicant: | Shenzhen Huanqiu Xuebao Technology Co., Ltd | |------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact: | Jiao Li,<br>Director | | Address: | Room 303, Building 2, Lane 2, Jinjuxia Road, Bao'an Avenue, Fuyong Street,<br>Bao'an District, Shenzhen, Guangdong, 518100, China | | Phone: | (+86-18774984036) | #### 2. Correspondent Information | Company: | Wenzhou ThiWe Business Consulting Co.,<br>Ltd. | |----------|-------------------------------------------------------------------------------------------------------------------------------| | Contact: | Kevin Zhang,<br>General Manager | | Address: | Room 1203, Building C, Hua'ou Jiayuan,<br>No.50 Tangjiaqiao South Road, Longwan<br>District, Wenzhou, Zhejiang, 325000, China | | Phone: | (+86-577-88201260) | | Email: | thiwe-tech@outlook.com | 3. Date prepared: September 20, 2021 #### 4. Device Information | Device Name: | 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: | LUBi Water Based Personal Lubricant | |----------------|-------------------------------------| | 510(k) Number: | K203257 | | Manufacturer: | Boya Biotechnology Co., Ltd. | The predicate device has not been subject to a design-related recall. #### 6. Device Description 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, {4}------------------------------------------------ glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles. Device specifications are listed in Table 1 below. #### Table 1: Device Specifications for Personal Lubricant | Property | Specification | | Personal Lubricant<br>K210857<br>Subject Device | LUBi Water based Personal<br>Lubricant<br>K203257<br>Predicate Device | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appearance | Viscous liquid | Device Classification Name | Lubricant, Personal | Lubricant, Personal | | Color | Clear, transparent | Indications for Use | Personal Lubricant is a water based<br>personal lubricant, for penile and/or<br>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. | LUBi Water Based Personal Lubrican<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 and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | | Odor | Odorless | Base type | Water | Water | | Viscosity | 10,000 - 20,000 mPa.s | Primary ingredients | Water, glycerol, hydroxyethyl cellulose,<br>potassium sorbate, methylparaben,<br>carbomer and triethanolamine | Water, glycerin, propylene glycol,<br>hydroxyethyl cellulose, sodium<br>hyaluronate, potassium sorbate, citric<br>acid, disodium EDTA | | pH | 5.0 - 6.0 | Rx/OTC | OTC | OTC | | Osmolality | 500 - 600 mOsm/kg | Sterile | No | No | | Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g | Appearance | Viscous liquid | Highly viscous liquid | | Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g | Color | Clear, transparent | Clear | | Presence of Pathogens (per USP <62>) | Specification | Odor | Odorless | Moderate sweet perfume | | Pseudomonas aeruginosa | Absent | Viscosity | 10,000-20,000 mPa.S | 28,500 - 30,000 mPa.S | | Staphylococcus aureus | Absent | pH | 5.0-6.0 | 7.5-8.0 | | Candida albicans | Absent | Osmolality | 500-600 mOsm/Kg | 1,000-1,100 mOsm/kg | | Escherichia coli | Absent | Total Aerobic Microbial<br>count (TAMC) | <100 cfu/g | <100 cfu/g | | Clostridia | Absent | Total Yeast and Mold Count<br>(TYMC) | <10 CFU/g | <10 CFU/g | | Salmonella | Absent | Absence of Pathogenic<br>Organisms | Yes | Yes | | Bile tolerant Gram-negative bacteria) | Absent | Antimicrobial Effectiveness<br>Tested | Yes | Yes | | Antimicrobial Effectiveness Testing (per USP <51>) | Specification | Condom Compatibility | Compatible with natural rubber latex and<br>polyisoprene | Compatible with natural rubber latex<br>and polyisoprene | | 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 | Biocompatibility Tested | Yes | Yes | | Yeast and Molds | No increase from the initial calculated count at<br>14 and 28 days | Shelf life | 3 years | 3 years | #### 7. Indications for Use Personal Lubricant is a water based personal lubricant, for penile 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 {5}------------------------------------------------ {6}------------------------------------------------ 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, appearance, odor, viscosity, pH, and osmolality. 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 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 accelerated 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 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 Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Personal Lubricant not to be compatible with polvurethane condoms. #### 10. Conclusion The results of the performance testing described above demonstrate that Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.