(57 days)
Unclear, Predicate Device(s)
No
The document describes a personal lubricant and its physical and chemical properties, with no mention of AI or ML technology in its function or development.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, which is not considered a therapeutic function.
No
The device is described as a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device description clearly indicates it is a physical product (a water-based personal lubricant) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly states that "Coconut Hybrid is a personal lubricant for penile application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a topical product applied to the body for physical lubrication, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, Coconut Hybrid is a personal lubricant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Coconut Hybrid is a personal lubricant for penile 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.
Product codes
NUC
Device Description
Coconut Hybrid is a water-based personal lubricant that is non- sterile, contains coconut oil, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, fractionated coconut oil, tremella fuciformis extract, hyaluronic acid, propanediol, DL lactic acid, xanthan gum, sodium benzoate, potassium sorbate, and natural coconut flavor. Coconut Hybrid is packaged in a 50 mL polyethylene tubes and is a personal lubricant 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 application
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
Biocompatibility: Coconut Hybrid has undergone biocompatibility testing including Cytotoxicity based on alternate testing comparable to ISO 10993-5: 2009. Human Repeat Insult Patch Testing (sensitization and irritation), and Acute Systemic Toxicity Testing per ISO 10993: 2017. The testing found that Coconut Hybrid is non-cytotoxic, nonsensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.
Shelf Life: Coconut Hybrid has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device could maintain its specifications (as shown in Table 1) over the duration of its shelf life.
Key Metrics
Not Found
Predicate Device(s)
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.
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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 19, 2024
Good Clean Love, Inc. % Abhishek Gurnani Regulatory Counsel Amin Wasserman Gurnani LLP 549 W. Randolph Street Suite 400 Chicago, Illinois 60661
Re: K242162
Trade/Device Name: Coconut Hybrid Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 22, 2024 Received: July 24, 2024
Dear Abhishek Gurnani:
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"
1
(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 OS 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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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
2
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,
Michael T. Bailey -S
For
Monica D. Garcia, PhD 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
3
Indications for Use
510(k) Number (if known)
Device Name Coconut Hybrid
Indications for Use (Describe)
Coconut Hybrid is a personal lubricant for penile 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)
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K242162 Page 1 of 4
510(k) Summary K242162 Coconut Hybrid
- (a)(1) Submitter/Owner: Good Clean Love, Inc. 207 West 5th Avenue Eugene, OR 97401 Contact: Wendy Strgar Phone: 541 344 4483 Email: Wendy@GoodCleanLove.com
Abhishek K. Gurnani Preparer/Contact: Amin Wasserman Gurnani LLP 230 W Monroe Street Suite 1405 Chicago IL 60606
Phone: 312 327 3325 Fax: 312 884 7352 Email: agurnani@awglaw.com
Summary Prepared: September 18, 2024
(a)(2) Subject Device Information
| Trade Name: | Coconut Hybrid |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Device Classification: | Class II |
| Product Code: | NUC (Lubricant, Personal) |
(a)(3) Predicate Device Information
| Trade Name: | Coconut Infused Hybrid Personal Lubricant |
|---|---|
| 501(k) Number: | K180712 |
| Manufacturer | United Consortium |
| Regulation Number: | 21 CFR 884.5300 |
| Device Classification: | Class II |
| Product Code: | NUC (Lubricant, Personal) |
The predicate device has not been subject to a design related recall.
- (a)(4) Device Description: Coconut Hybrid is a water-based personal lubricant that is non- sterile, contains coconut oil, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, fractionated coconut oil, tremella fuciformis extract, hyaluronic acid, propanediol, DL lactic acid, xanthan gum, sodium benzoate, potassium sorbate, and natural coconut flavor. Coconut Hybrid is packaged in a 50 mL polyethylene tubes and is a personal lubricant for
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over the counter (OTC) use.
Device specifications are listed in Table 1 below.
| Parameter | Specification | Method |
|---|---|---|
| Appearance | Gel | Visual Inspection |
| Color | Opaque | Visual Inspection |
| Odor | Characteristic (coconut) | Olfactory Inspection |
| pH | 3.5 – 4.2 | USP |
| Viscosity | 8,000 - 59,000 cPs | USP |
| Osmolality | 200 – 400 mOsm/kg | USP |
| Antimicrobial Effectiveness | Category 2 product: Bacteria | |
| should show not less than 2.0 log | ||
| reduction at 14 days and no | ||
| increase from 14-day count at the | ||
| 28-day count. Yeast and molds | ||
| should show no increase from the | ||
| initial calculated count at 14 and | ||
| 28 days. | USP | |
| Total Aerobic Microbial Count | ||
| Total Yeast and Mold Count | ||
| Absence of Pathogenic Organisms | ||
| (Pseudomonas aeruginosa, | ||
| Staphylococcus aureus, Candida | ||
| albicans, Escherichia coli, | ||
| Salmonella, Clostridium Species) | Absent | USP |
Table 1: Subject Device Specifications
- (a)(5) Indications for Use Statement: Coconut Hybrid 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. This product is not compatible with polyurethane condoms.
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(a)(6) Comparison of Technological Characteristics
| K242162 | K180712 | |
|---|---|---|
| Subject Device | Predicate | |
| Sponsor | Coconut Hybrid | Coconut Infused Hybrid Personal |
| Lubricant | ||
| Regulation Number | 844.5300 | 844.5300 |
| Product Code | ||
| Device Class | NUC II | NUC II |
| Indications for Use | Coconut Hybrid 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. This | ||
| product is not compatible with | ||
| polyurethane condoms. | Coconut Infused Hybrid 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. | ||
| Physical Features | Opaque Gel | White to off-white liquid |
| Water-based | Yes | Yes |
| Primary Ingredients | Water, hydroxyethylcellulose, | |
| fractionated coconut oil, tremella | ||
| fuciformis extract, hyaluronic acid, | ||
| propanediol, DL lactic acid, xanthan | ||
| gum, sodium benzoate, potassium | ||
| sorbate, and natural coconut flavor | Water (Aqua), Propylene Glycol, | |
| Caprylic/Capric Triglyceride, Cocos | ||
| Nucifera (Coconut) Oil, Flavor | ||
| (Aroma), Phenoxyethanol, | ||
| Polyacrylate 13, Cellulose Gum | ||
| (sodium carboxymethylcellulose), | ||
| Raphanus Sativus (Radish) Seed | ||
| Extract, Polyisobutene, Polysorbate | ||
| 20, PEG-45M | ||
| pH | 3.5 – 4.2 | 5.7 – 6.3 |
| Osmolality | 200 – 400 mOsm/Kg | 450 – 900 mOsm/kg |
| Viscosity | 8,000 – 59,000 cps | 20,000 – 31,000 cps |
| Sterile | No | No |
| Condom | ||
| Compatibility | Natural Rubber Latex and | |
| Polyisoprene | Natural Rubber Latex and | |
| Polyisoprene | ||
| Biocompatibility | ||
| Tested | Yes | Yes |
| Antimicrobial | ||
| Tested (USP , | ||
| USP , USP | ||
| ) | Yes | Yes |
Table 2. Technological Characteristics of Coconut Hybrid as Compared to the Predicate
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The subject and predicate devices do not have identical indications for use statements, as the predicate is also intended for anal use. This difference does not represent a different intended use, but rather a more limited use for the subject device, as both devices are intended for providing additional lubrication during intimate sexual activity. As noted in the table above, the subject and predicate device have differences in technological characteristics (e.g., formulations, specifications, etc.). These differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
(b) Summary of Performance Data
Biocompatibility: Coconut Hybrid has undergone biocompatibility testing including Cytotoxicity based on alternate testing comparable to ISO 10993-5: 2009. Human Repeat Insult Patch Testing (sensitization and irritation), and Acute Systemic Toxicity Testing per ISO 10993: 2017. The testing found that Coconut Hybrid is non-cytotoxic, nonsensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.
Shelf Life: Coconut Hybrid has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device could maintain its specifications (as shown in Table 1) over the duration of its shelf life.
Conclusion: The results of the performance testing described above demonstrate that the Coconut Hybrid Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.