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.

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, 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Personal Lubricant, not an AI/ML medical device. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document.

The document discusses the substantial equivalence of the Personal Lubricant to a predicate device based on:

Indications for Use: Same as predicate.
Technological Characteristics: Similarities and differences in formulation, appearance, odor, viscosity, pH, and osmolality are compared.
Non-Clinical Performance Testing:
- Biocompatibility: Tested according to ISO 10993 standards.
- Shelf-Life: Demonstrated to maintain specifications for 3 years.
- Condom Compatibility: Tested according to ASTM D7661-10(R) 2017 for compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.

The document does not describe an AI/ML device or its performance criteria.

Summary

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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.

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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 (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

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Indications for Use

510(k) Number (if known) K210857

Device Name Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K210857 Personal Lubricant

1. Submitter Information

Applicant:	Shenzhen Huanqiu Xuebao Technology Co., Ltd
Contact:	Jiao Li,Director
Address:	Room 303, Building 2, Lane 2, Jinjuxia Road, Bao'an Avenue, Fuyong Street,Bao'an District, Shenzhen, Guangdong, 518100, China
Phone:	(+86-18774984036)

2. Correspondent Information

Company:	Wenzhou ThiWe Business Consulting Co.,Ltd.
Contact:	Kevin Zhang,General Manager
Address:	Room 1203, Building C, Hua'ou Jiayuan,No.50 Tangjiaqiao South Road, LongwanDistrict, Wenzhou, Zhejiang, 325000, China
Phone:	(+86-577-88201260)
Email:	thiwe-tech@outlook.com

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

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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 LubricantK210857Subject Device	LUBi Water based PersonalLubricantK203257Predicate Device
Appearance	Viscous liquid	Device Classification Name	Lubricant, Personal	Lubricant, Personal
Color	Clear, transparent	Indications for Use	Personal Lubricant is a water basedpersonal lubricant, for penile and/orvaginal application, intended tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.	LUBi Water Based Personal Lubricanis a personal lubricant for penileand/or vaginal application, intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
Odor	Odorless	Base type	Water	Water
Viscosity	10,000 - 20,000 mPa.s	Primary ingredients	Water, glycerol, hydroxyethyl cellulose,potassium sorbate, methylparaben,carbomer and triethanolamine	Water, glycerin, propylene glycol,hydroxyethyl cellulose, sodiumhyaluronate, potassium sorbate, citricacid, 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 Microbialcount (TAMC)	<100 cfu/g	<100 cfu/g
Clostridia	Absent	Total Yeast and Mold Count(TYMC)	<10 CFU/g	<10 CFU/g
Salmonella	Absent	Absence of PathogenicOrganisms	Yes	Yes
Bile tolerant Gram-negative bacteria)	Absent	Antimicrobial EffectivenessTested	Yes	Yes
Antimicrobial Effectiveness Testing (per USP <51>)	Specification	Condom Compatibility	Compatible with natural rubber latex andpolyisoprene	Compatible with natural rubber latexand polyisoprene
Bacteria	Meets USP <51> criteria for category 2.No less than 2.0 log reduction from initialcount at 14 days and no increase from the 14-day count at 28 days	Biocompatibility Tested	Yes	Yes
Yeast and Molds	No increase from the initial calculated count at14 and 28 days	Shelf life	3 years	3 years

7. Indications for Use

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

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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, 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.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.