(307 days)
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The intended use states that it is for lubrication and moisture to enhance sexual activity, not for treating or preventing a disease or condition.
No
The "Intended Use / Indications for Use" states that the device is a personal lubricant intended to moisturize and lubricate to enhance sexual activity, which is not a diagnostic purpose.
No
The device description clearly states it is a physical product (personal lubricant) with a gel consistency, provided in tube containers, and composed of water-solvent organic materials. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a direct application to the body for a physical purpose.
- Device Description: The description details the composition as a water-solvent organic material gel for lubrication.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- Anatomical Site: The application is to external or internal body surfaces, not for analyzing samples taken from the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This personal lubricant does not fit that description.
N/A
Intended Use / Indications for Use
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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, polyisoprene, and polyurethane condoms.
Product codes
NUC
Device Description
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: Testing has established that lubricants met specifications for appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms. Shelf-life has been established at one-year. Condom compatibility testing following ASTM D7661-10 concluded that the lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Biocompatibility testing for Vaginal Mucosa Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2006), Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010), and Cytotoxicity (MatTek EpiVaginal Tissue Model) all had acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
November 21, 2019
Good Clean Love, Inc. % Steven Chernoff Vice President Drug & Device Development Co., Inc. P.O. Box 3515 Redmont. WA 98073
Re: K150094
Trade/Device Name: Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: September 30, 2015 Received: October 2, 2015
Dear Steven Chernoff:
This letter corrects our substantially equivalent letter of November 19, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150094
Device Name
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
Indications for Use (Describe)
Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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, polyisoprene, and 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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510(k) Summary (21 CFR 807.92) Section 5.
Date prepared: Nov. 19. 2015
Submitter:
Good Clean Love, Inc. 207 West 5th Avenue Eugene, OR 97401 Contact Person: Wendy Strgar Ph: 541-344-4483 Fax: 541-685-1335
Proprietary name:
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Common name:
Personal Lubricant
Classified name:
Condom
CFR 884.5300 Class II Product code NUC
Intended use:
Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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, polyisoprene, and polyurethane condoms.
Predicate device:
The Good Clean Love personal lubricants are substantially equivalent to Aloe Cadabra personal lubricants (K124044).
Description of device:
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Summary of technological characteristics compared to predicate devices:
Both the Good Clean Love products and its predicate device, Aloe Cadabra, consist of 95% organic aloe vera. Both products are compatible with natural rubber latex and polyisoprene condoms and are biocompatible.
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Non-clinical testing:
Testing has established that lubricants met specifications for appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms. Shelf-life has been established at one-year.
Condom compatibility testing following ASTM D7661-10 concluded that the lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Biocompatibility testing for Vaginal Mucosa Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2006), Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010), and Cytotoxicity (MatTek EpiVaginal Tissue Model) all had acceptable results.
Conclusion:
The conclusions drawn from the non-clinical tests and predicate comparison demonstrate that the subject device performs as well as the legally marketed device and the Good Clean Love's personal lubricants are substantially equivalent to the cited predicate device for intended use and technological characteristics.