HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
Device Facts
| Record ID | K253989 |
|---|---|
| Device Name | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) |
| Applicant | Maxigen Biotech, Inc. |
| Product Code | NUC · Obstetrics/Gynecology |
| Decision Date | Sep 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
HARU Orgasm by jack herer water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. HARU Orgasm water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. HARU STEAMY water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Device Story
Water-based personal lubricants; clear, viscous gels; applied topically to penile/vaginal areas to reduce friction during sexual activity. Packaged in 155ml PET bottles with PP/PE caps. Ingredients include water, glycerine, 1,3-propanediol, sodium pyrrolidone carboxylic acid, hydroxyethylcellulose, methylparaben, sodium carboxymethyl cellulose, PEG-40 hydrogenated castor oil, and vanillyl butyl ether. Over-the-counter use; intended to supplement natural lubrication. Non-sterile. Compatibility testing confirms safety with natural rubber latex condoms; incompatibility with polyisoprene and polyurethane condoms noted.
Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) showed no adverse effects. Shelf-life validated via accelerated aging (2 years). Condom compatibility tested per ASTM D7661-2023.
Technological Characteristics
Water-based gel; pH 5.0–7.0; viscosity 3500–7500 cps; osmolality 250–550 mOsm/kg. Materials: PET bottle, PP/PE cap, PE inner plug. Preservatives: methylparaben. Testing standards: USP <791>, USP <912>, USP <785>, USP <61>, USP <62>, USP <51>, ISO 10993, ASTM D7661-2023.
Indications for Use
Indicated for penile and/or vaginal application to lubricate and moisturize, enhancing comfort during intimate sexual activity and supplementing natural lubrication. Compatible with natural rubber latex condoms; incompatible with polyisoprene and 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
- Azul Personal Lubricant (K141034)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 3, 2026
Maxigen Biotech, Inc.
Cheng-Han Chou
Regulatory Affairs
#88, Keji 1st Rd., Guishan Dist.,
Taoyuan,
TAIWAN
Re: K253989
Trade/Device Name: HARU Orgasm by jack herer water based lubricant (WL-OJ);
HARU Orgasm water based lubricant (WL-OR);
HARU STEAMY water based lubricant (WL-ST)
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II
Product Code: NUC
Dated: December 12, 2025
Received: December 12, 2025
Dear Cheng-Han Chou:
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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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
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K253989 - Cheng-Han Chou
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253989
Device Name
HARU Orgasm by jack herer water based lubricant (WL-OJ)
HARU Orgasm water based lubricant (WL-OR)
HARU STEAMY water based lubricant (WL-ST)
Indications for Use (Describe)
HARU Orgasm by jack herer water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
HARU Orgasm water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
HARU STEAMY water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and 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.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
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K253989
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# 510(K) Summary – K253989
Date Prepared: September 2, 2026
## 1. SUBMITTER TYPE INFORMATION
Name: Maxigen Biotech Inc.
Address: No.88, Keji 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Phone: +886-3-3287222
Fax: +886-3-3287333
Contact: Cheng Han, Chou
## 2. DEVICE INFORMATION
Trade Names: HARU Orgasm by jack herer water based lubricant (WL-OJ)
HARU Orgasm water based lubricant (WL-OR)
HARU STEAMY water based lubricant (WL-ST)
Common Name: Personal Lubricant
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Product Code: NUC (lubricant, personal)
Class: Class II
## 3. PREDICATE DEVICE
Predicate device: Azul Personal Lubricant (K141034)
The predicate device has not been subject to a design-related recall.
## 4. DEVICE DESCRIPTION
HARU Orgasm by jack herer water based lubricant, HARU Orgasm water based lubricant, and
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K253989
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HARU STEAMY water based lubricant are non-sterile, water-based personal lubricants intended for over-the-counter (OTC) use. These products are compatible with natural rubber latex condoms but are not compatible with polyisoprene and polyurethane condoms.
Each product is packaged in a 155ml polyethylene terephthalate (PET) bottle with a screw-on polypropylene (PP)/polyethylene (PE) flat cap and a PE inner plug. The lubricants are clear, colorless, viscous gels composed of purified water, glycerine, 1,3-propanediol, sodium pyrrolidone carboxylic acid, hydroxyethylcellulose, methylparaben, sodium carboxymethyl cellulose, PEG-40 hydrogenated castor oil, and vanillyl butyl ether.
The specifications of the subject devices are described in Table 1 below.
Table 1. Device Specifications
| Parameter | Method | Specification |
| --- | --- | --- |
| Appearance | Visual | Clear Gel |
| Odor | Olfactory | Characteristic odor |
| pH | USP<791> | 5.0~7.0 |
| Viscosity (cps) | USP<912> | 3500~7500 |
| Osmolality (mOsm/kg) | USP<785> | 250~550 (1:9 dilution) |
| Total Aerobic Microbial Count (TAMC) | USP<61> | Less than 100 cfu/mL |
| Total Yeast and Mold Count (TYMC) | USP<61> | Less than 10 cfu/mL |
| Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans) | USP<62> | Absent |
| Antimicrobial Preservation | USP<51> | Meets USP <51> acceptance criteria for Category 2 products. Category 2, bacteria should show not be less than 2.0 log reduction at 14 days and no increase from 14-day Count at the 28 day count. Yeasts and molds should show no increase from the initial calculated count at 14 and 28 days. |
## 5. INDICATIONS FOR USE
HARU Orgasm by jack herer water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
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K253989
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HARU Orgasm water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
HARU STEAMY water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
## 6. COMPARISION OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICE
| Device & Predicate Device(s): | Subject device | | | Predicate device | Comparison |
| --- | --- | --- | --- | --- | --- |
| | HARU Orgasm by jack herer water based lubricant | HARU Orgasm water based lubricant | HARU STEAMY water based lubricant | Azul personal lubricant(K141034) | |
| **Indications for Use** | HARU Orgasm by jack herer water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. | HARU Orgasm water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. | HARU STEAMY water based lubricant is a 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. | Azul personal lubricant is a 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. | Similar |
| **Regulation Number** | 884.5300 | 884.5300 | 884.5300 | 884.5300 | Same |
| **Product Code** | NUC | NUC | NUC | NUC | |
| **Device Class** | II | II | II | II | |
| **Condom Compatibility** | NRL and polyisoprene | NRL and polyisoprene | NRL and polyisoprene | NRL and polyisoprene | Same |
| **Base type** | Water | Water | Water | Water | Same |
| **Primary Ingredients** | Water, Glycerine, 1,3-Propanediol, Sodium Pyrrolidone Carboxylic Acid, Hydroxyethylcellulose, Methylparaben, Sodium carboxymethyl cellulose, PEG-40 Hydrogenated Castor Oil | Water, Glycerine, 1,3-Propanediol, Sodium Pyrrolidone Carboxylic Acid, Hydroxyethylcellulose, Methylparaben, Sodium carboxymethyl cellulose, PEG-40 Hydrogenated Castor Oil | Water, Glycerine, 1,3-Propanediol, Sodium Pyrrolidone Carboxylic Acid, Hydroxyethylcellulose, Methylparaben, Sodium carboxymethyl cellulose, PEG-40 Hydrogenated Castor Oil | Full ingredient list not available. Includes: Water, aloe, vitamin E, sodium hyaluronate, hydroxyethylcellulose, methylparaben | Different |
| **Over the counter use** | Yes | Yes | Yes | Yes | Same |
| **Sterile** | No | No | No | No | Same |
| **Appearance** | Clear Gel | Clear Gel | Clear Gel | Clear | Same |
| **Color** | Clear and colorless | Clear and colorless | Clear and colorless | Clear | Same |
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K253989
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| **Odor** | Characteristic odor | Characteristic odor | Characteristic odor | Not available | NA |
| --- | --- | --- | --- | --- | --- |
| **Viscosity** | 3500–7500 | 3500–7500 | 3500–7500 | Not available | NA |
| **pH** | 5.0–7.0 | 5.0–7.0 | 5.0–7.0 | 5.9–6.9 | Similar |
| **Osmolality** | 250–550 (1:9 dilution) | 250–550 (1:9 dilution) | 250–550 (1:9 dilution) | Not available | NA |
| **Antimicrobial Tested** | Meets USP <51> acceptance criteria for Category 2 products. | Meets USP <51> acceptance criteria for Category 2 products. | Meets USP <51> acceptance criteria for Category 2 products. | Yes | Same |
| **TAMC** | < 100 cfu/g | < 100 cfu/g | < 100 cfu/g | Not available | NA |
| **TYMC** | <10 cfu/g | <10 cfu/g | <10 cfu/g | Not available | NA |
| **Absence of pathogenic organisms** | Absence | Absence | Absence | Absence | Same |
| **Shelf life** | 2 years | 2 years | 2 years | 2 years | Same |
The subject devices and the predicate device share similar technological characteristics, including viscosity, pH, preservatives, and thickeners. Although the subject devices differ from the predicate device in chemical composition, osmolality, and odor, these differences do not raise different questions of safety and effectiveness. The subject devices and the predicate device have the same intended use, principle of operation, physical form, and similar technological characteristics.
## 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
### Biocompatibility
Biocompatibility testing on the subject lubricants 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 (ISO 10993-5:2009)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021)
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrate that the subject lubricants are non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
### Shelf Life
The subject devices have a shelf life of 2 years based on results of an accelerated aging stability study. Evaluation of the device specifications outlined in Table 1 on were conducted at baseline and aged samples, and results were met for all parameters.
### Condom Compatibility
The compatibility of the subject devices with condoms were evaluated in accordance with
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ASTM D7661-2023 “Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.” The results of this test showed that the subject devices are compatible with natural rubber latex condoms. Results showed the subject devices are not compatible with polyisoprene and polyurethane condoms.
# 8. Conclusion
The results of the testing described above demonstrate that the HARU Orgasm by jack herer water based lubricant, HARU Orgasm water based lubricant, and HARU STEAMY water based lubricant are as safe and effective as the predicate device supports a determination of substantial equivalence.
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