JO Agapé Original Personal Lubricant is a water-based 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.

MUSE Essence Water-Based Lubricant is a water-based 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 lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#LubeLife Water-Based Lubricant is a water-based 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.

#LubeLife Water-Based Anal Lubricant is a water-based 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 lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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. All of these devices contain the same formulation.

AI/ML Overview

The provided document is a 510(k) premarket notification for personal lubricants. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study data for a novel device or AI/ML-driven medical device. Therefore, much of the requested information (like AI assistance effect size, expert qualifications, sample size for training sets, etc.) is not applicable or available in this context.

However, I can extract information related to the device specifications and the performance studies conducted to show that the device meets certain standards.

Here's the available information relevant to acceptance criteria and performance, as best as can be inferred from the document:

1. A table of acceptance criteria and the reported device performance

The document provides "Device Specifications" which act as acceptance criteria for the physical and chemical properties, and microbial limits of the lubricants. It also states the results of performance tests.

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear, viscous liquid	Clear, viscous liquid (stated in Device Description)
Color	Clear, water white	Clear, water white (stated in Device Description)
Odor	Odorless	Odorless (reported in Table 1)
Viscosity (cps)	2400 cps to 3100 cps	Within 2400 cps to 3100 cps (reported in Table 1)
pH	3.6 to 4.5	Within 3.6 to 4.5 (reported in Table 1)
Specific Gravity	1.020 to 1.026	Within 1.020 to 1.026 (reported in Table 1)
Osmolality	600 to 700 mOsm/kg	Within 600 to 700 mOsm/kg (reported in Table 1)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.	Meets USP <51> acceptance criteria. (reported in Table 1)
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 10 cfu/g	Less than 10 cfu/g (reported in Table 1)
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Less than 10 cfu/g (reported in Table 1)
Presence of Pathogens per USP <62>	Absent for listed pathogens	Absent for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans (reported in Table 1)
Biocompatibility	Passing reactivity score (cytotoxicity, irritation), Non-sensitizing, Non-systemically toxic	Slightly cytotoxic (passing), Mildly irritating (passing), non-sensitizing, non-systemically toxic (Summary of Performance Data)
Condom Compatibility	Compatible with Natural Rubber Latex and Polyisoprene condoms	Compatible with Natural Rubber Latex and Polyisoprene condoms; Not compatible with Polyurethane condoms (Summary of Performance Data)
Shelf life	2 years (after accelerated aging studies)	2 years (Summary of Performance Data)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test conducted (e.g., number of lubricant samples for chemical/microbial tests, number of animals for biocompatibility, or number of condoms for compatibility).

Provenance: The tests were performed in accordance with recognized standards (USP, ISO, ASTM). The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but given they are performance tests for regulatory submission, they would generally be prospective studies conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a personal lubricant, not an interpretive medical device like an AI/ML diagnostic. The "ground truth" here refers to objective physical, chemical, and biological properties measured via standardized lab tests, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable for this type of device and testing. Test results are typically objective measurements against a defined specification.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML-driven device or an interpretive device requiring human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical product (lubricant), not an algorithm.

7. The type of ground truth used

The "ground truth" for the acceptance criteria and performance evaluations are based on:

Standardized Test Methods: USP (United States Pharmacopeia), ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials) standards for chemical composition, physical properties, microbiological contamination, biocompatibility, and condom compatibility.
Objective Measurements: Laboratory measurements against predefined numerical or qualitative specifications.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device as it is not an AI/ML system.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 4, 2019

United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K183384

Trade/Device Name: JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 5, 2018

Dear Stephanie Morris:

Received: December 6, 2018

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K183384

Device Name

JO Agapé Original Personal Lubricant MUSE Essence Water-Based Lubricant #LubeLife Water-Based Lubricant #LubeLife Water-Based Anal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

_ | 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 contains a logo and some text. The logo is a stylized letter 'U' in blue and gray, with the words 'UNITED CONSORTIUM' written below it in a smaller font. To the right of the logo, the text 'JO Agap' is written in bold, followed by '#Lub' on the next line. The text is black and appears to be part of a larger message or title.

JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

510(k) Summary

510(k) Owner:	United Consortium
Street Address:	29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:	Stephanie MorrisGlobal Regulatory SpecialistBruce AlbertHead of Technical Services
Contact Numbers:	Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800
Summary Preparation Date:	December 5, 2018
Trade Name:	JO Agapé Original Personal LubricantMUSE Essence Water-Based Lubricant#LubeLife Water-Based Lubricant#LubeLife Water-Based Anal Lubricant
Device Classification:	Common Name: Personal LubricantClassification Name: CondomClassification Number: 21 CFR § 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II
Predicate Device:	Product Name: Wet Original® Personal Lubricant510(k) Number: K160211Manufacturer: Trigg Laboratories, Inc.Product Code: NUC (lubricant, personal)Device Class: Class II

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

Device Description:

JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water

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Image /page/4/Picture/2 description: The image features a stylized logo for "UNITED CONSORTIUM." The logo consists of a large, abstract shape resembling the letter 'U,' with the left side in a dark blue color and the right side in a light gray. The words "UNITED CONSORTIUM" are printed in a smaller, sans-serif font below the shape, aligned to the left.

JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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. All of these devices contain the same formulation.

The JO Agapé Original Personal Lubricant product is to be sold as an over-the-counter (OTC) product in sizes of 1 fl. oz./30 mL 2 fl. oz./60 mL and 4 fl. oz./120 mL. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc tops. The 2 oz. and 4 oz. size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This product is also available in 3 mL and 10 mL polyester-faced laminated pouches.

The MUSE Essence Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with matte black Polypropylene (PP) pump closures. The bottles are then placed in Solid Bleached Sulfate (SBS) cartons and sealed with a clear Biaxially-Oriented Polypropylene (BOPP) sticker on the top and bottom of each carton. This product is also available in 10 mL size polyester-faced laminated pouches.

#LubeLife Water-Based Lubricant product is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL and 12 fl. oz./360 mL sizes. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

LubeLife Water-Based Anal Lubricant product is to be sold as an over-the-counter (OTC) product in 12 fl. oz./360 mL size bottles. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

The device specifications are listed in the table below:

Table 1: Device Specifications for JO Agapé Original Personal Lubricant, MUSE Essence
Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based
Anal Lubricant
Property	Specification
Appearance	Clear, viscous liquid
Color	Clear, water white
Odor	Odorless
Viscosity (cps)	2400 cps to 3100 cps
pH	3.6 to 4.5

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Image /page/5/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades of gray and blue. The blue portion of the 'U' is in the foreground, while the gray portion is behind it, creating a layered effect. Below the logo, the words 'UNITED CONSORTIUM' are written in a sans-serif font.

IO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

Specific Gravity	1.020 to 1.026
Osmolality	600 to 700 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria for Category 2 products.
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 10 cfu/g
Total yeast and mold count (TYMC) per USP <61> 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

Indications for Use:

MUSE Essence Water-Based Lubricant is a water-based 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.

#LubeLife Water-Based Anal Lubricant is a water-based 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.

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Image /page/6/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two tones. The left side of the 'U' is a dark blue, while the right side is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.

JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

Table 2: Comparator Table for Subject Devices – JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant and Predicate Device Wet Original® Personal Lubricant

Feature	JO Agapé Original Personal LubricantMUSE Essence Water-Based Lubricant#LubeLife Water-Based Lubricant#LubeLife Water-Based Anal Lubricant	Wet Original® PersonalLubricant (K160211)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	JO Agapé Original Personal Lubricant isa water-based personal lubricant forpenile, anal and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.MUSE Essence Water-Based Lubricantis a water-based personal lubricant forpenile, anal and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.#LubeLife Water-Based Lubricant is awater-based personal lubricant forpenile, anal and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.	The Trigg Laboratories WetOriginal® Personal Lubricant isa personal lubricant for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex,polyisoprene, andpolyurethane condoms.
Feature	JO Agapé Original Personal LubricantMUSE Essence Water-Based Lubricant#LubeLife Water-Based Lubricant#LubeLife Water-Based Anal Lubricant	Wet Original® PersonalLubricant (K160211)
	#LubeLife Water-Based Anal Lubricantis a water-based personal lubricant forpenile, anal and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Propanediol, hydroxyethylcellulose,water (aqua), gluconolactone, sodiumbenzoate, citric acid	Glycerin, water, pentyleneglycol, potassium sorbate,sodium carboxymethylcellulose
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex, Polyisoprene	Latex, Polyisoprene,Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	2 years

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Image /page/7/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 layered effect. Below the 'U', the words 'UNITED CONSORTIUM' are written in a sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'. The logo has a clean and modern design.

JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

The subject and predicate devices have similar indications for use. The indications for the subject devices has been expanded to also include anal use. This change does not represent a new intended use as the intended use of these devices 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, and condom compatibility. The different technological characteristics of the subject devices does 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 –

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JO Agapé Original Personal Lubricant / MUSE Essence Water-Based Lubricant / #LubeLife Water-Based Lubricant / #LubeLife Water-Based Anal Lubricant

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

The results of this testing demonstrated that the subject lubricants are only slightly cytotoxic with a passing reactivity score, mildy-irritating with a passing reactivity score, non-sensitizing and non-systemically toxic.

Shelf-Life:

The subject devices are non-sterile personal lubricants with a two-year shelf-life in accordance with the results of accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap, bottles with pump closure and pouches. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life.

Condom Compatibility:

The compatibility of the subject devices 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 Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that the JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are 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.