K Number
K250629
Device Name
Sutil Rich Personal Lubricant
Date Cleared
2025-05-02

(60 days)

Product Code
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutil Rich Personal Lubricant is a 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. The product is not compatible with polyurethane condoms.
Device Description
Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.
More Information

No.
The device is a personal lubricant, a chemical product, and does not contain any electronic or computational components that could host an AI model.

No.
A therapeutic device is typically intended to treat or prevent a disease or conditions, or to affect the structure or function of the body. This product is intended to moisturize and lubricate to enhance comfort during intimate sexual activity, which is not a therapeutic purpose.

No

Explanation: The "Intended Use / Indications for Use" section states that Sutil Rich Personal Lubricant is intended "to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." There is no mention of diagnosing any condition or disease.

No

The device is a personal lubricant, a physical product composed of various chemical ingredients and packaged in tubes. Its description, intended use, and performance studies all relate to its physical properties and biological compatibility, not to software.

No.
This device is a personal lubricant for topical application, not intended for in vitro diagnostic purposes.

N/A

Intended Use / Indications for Use

Sutil Rich Personal Lubricant is a 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. The product is not compatible with polyurethane condoms.

Product codes

NUC

Device Description

Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penile and/or vaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Shelf-life Testing: The subject device has a 2-year shelf-life based on the results of real-time aging. Testing on samples showed that the subject device met all device specifications listed in Table 1 above across the device shelf-life.
Biocompatibility Testing: Biocompatibility testing was performed in accordance with the 2023 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", as follows:

  • Cytotoxicity per ISO 10993-5:2009
  • Skin Irritation and Sensitization – Human Repeat Insult Patch Test (HRIPT), an alternative test method to ISO 10993-10:2021 and ISO 10993-23:2021
  • Acute Systemic Toxicity per ISO 10993-11:2017
    The results of this testing demonstrate that the subject lubricants are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
    Condom Compatibility: The compatibility of the subject devices with condoms was evaluated in accordance with ASTM D7661-18, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and were determined to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.

Key Metrics

Not Found

Predicate Device(s)

K211998

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

FDA 510(k) Clearance Letter - Sutil Rich Personal Lubricant

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 2, 2025

Hathor Professional Skincare Ltd.
℅ Rob Packard
President
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury, Vermont 05738

Re: K250629
Trade/Device Name: Sutil Rich Personal Lubricant
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: NUC
Dated: March 2, 2025
Received: March 3, 2025

Dear Rob Packard:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250629 - Rob Packard Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

Page 3

K250629 - Rob Packard Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,

Monica D. Garcia -S

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250629

Device Name
Sutil Rich Personal Lubricant

Indications for Use (Describe)
Sutil Rich Personal Lubricant is a 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. The product is not compatible with polyurethane condoms.

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)

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"

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

Hathor Professional Skincare Ltd.
K250629
Page 1 of 4

510(k) Summary

510(k) SUMMARY (K250629)

I. SUBMITTER

Company Name: Hathor Professional Skincare Ltd.
Address: 2618 Roseberry Ave.
City, State, Zip: Victoria, BC V8R 3T7 Canada
Telephone: +1.778.679.0037
Contact Person: Carolyn (Mellta) Swift
Date Prepared: April 30, 2025

II. DEVICE

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

III. PREDICATE DEVICE

Predicate Manufacturer: Good Clean Love, Inc.
Predicate Trade Name: Desnuda Reflect
Predicate 510(k): K211998

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

IV. DEVICE DESCRIPTION

Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.

The device specifications are listed in Table 1 below:

Table 1: Device Specifications for Sutil Rich Personal Lubricant

ParameterTest MethodSpecification
AppearanceVisualViscous liquid
ColorVisualClear
OdorOrganolepticNo scent
pHUSP5.8 – 6.2

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Hathor Professional Skincare Ltd.
K250629
Page 2 of 4
510(k) Summary

Viscosity (cps)USP30,000 – 40,000 cps
Osmolality (mOsm/kg)USP550 - 700 (1:5 dilution)
Antimicrobial EffectivenessUSPMeets USP criteria for category 2. Bacteria: 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 days and 28 days.
Total Microbial Count (TAMC)USP

V. INDICATIONS FOR USE

Sutil Rich Personal Lubricant is a 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. The product is not compatible with polyurethane condoms.

VI. 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 devices:

Subject Devices (K241443)Predicate Device (K211998)
Indications for UseSutil Rich Personal Lubricant is a 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 polyisopreneDesnuda Reflect is a 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

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Hathor Professional Skincare Ltd.
K250629
Page 3 of 4
510(k) Summary

Subject Devices (K241443)Predicate Device (K211998)
condoms. The product is not compatible with polyurethane condoms.latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Rx/OTCOTCOTC
Water-basedYesYes
IngredientsWater, Propanediol (bio 1,3-propanediol), Hyaluronic Acid, D-Glucono-1,5-lactone, Sodium Benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Organic Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder ExtractWater, Hyaluronic Acid, Hydroxyethylcellulose, Xanthan Gum, Zemea Propanediol, Sodium Benzoate, Potassium Sorbate, DL Lactic Acid
SterileNoNo
Condom CompatibilityNatural Rubber Latex and Polyisoprene CondomsNatural Rubber Latex and Polyisoprene Condoms
Shelf Life2 years1 year
Physical Characteristics Tested (appearance, color, odor)YesYes
pH TestedYesYes
Osmolality TestedYesYes
Biocompatibility TestedYesYes
Microbiology Tested (absence of pathogenic organisms, TAMC, and TYMC)YesYes
Antimicrobial Effectiveness TestedYesYes

The subject device and predicate device have the same intended use (i.e., provides lubrication during intimate sexual activity). The subject device and predicate device have different technological characteristics, including variations in formulations, specifications, and shelf-life durations. The differences in the technological characteristics of the subject and predicate do not raise different questions of safety and effectiveness.

VII. SUMMARY OF PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Shelf-life Testing
The subject device has a 2-year shelf-life based on the results of real-time aging. Testing on samples showed that the subject device met all device specifications listed in Table 1 above across the device shelf-life.

Biocompatibility Testing
Biocompatibility testing was performed in accordance with the 2023 FDA guidance document "Use of

Page 8

Hathor Professional Skincare Ltd.
K250629
Page 4 of 4
510(k) Summary

International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process", as follows:

  • Cytotoxicity per ISO 10993-5:2009
  • Skin Irritation and Sensitization – Human Repeat Insult Patch Test (HRIPT), an alternative test method to ISO 10993-10:2021 and ISO 10993-23:2021
  • Acute Systemic Toxicity per ISO 10993-11:2017

The results of this testing demonstrate that the subject lubricants are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.

Condom Compatibility
The compatibility of the subject devices with condoms was evaluated in accordance with ASTM D7661-18, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and were determined to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.

VIII. CONCLUSIONS

The results of the performance testing described above demonstrate that Sutil Rich Personal Lubricant is as safe and effective as the predicate device and support a determination of substantial equivalence.