(224 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No.
The primary purpose of this device is to moisturize and lubricate to enhance comfort during sexual activity, not to treat or prevent a disease or condition. While it may provide relief from dryness, it does not aim to cure a medical ailment.
No
The intended use of the device is to moisturize and lubricate for sexual activity, not to diagnose any medical condition.
No
The device description clearly states it is a physical product (a lubricant) composed of various ingredients and packaged in bottles. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance the ease and comfort of intimate sexual activity. This is a topical application for lubrication, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a water-based lubricant with specific ingredients and packaging. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life. These are relevant to a personal lubricant's safety and effectiveness for its intended use, not to the accuracy of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
In summary, the device is a personal lubricant, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Aloe Glide 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. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, 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, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant 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
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: Aloe Glide 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 10993-11:2017. The testing found that Aloe Glide is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
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" 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: Aloe Glide has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
September 25, 2019
Desert Harvest, Inc % Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 S. Wacker Drive, Suite 2000 Chicago, IL 60606
Re: K190323 Trade/Device Name: Aloe Glide Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 23, 2019 Received: August 26, 2019
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 (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 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
1
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,
Sharon M. Andrews 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) K190323
Device Name Aloe Glide Lubricant
Indications for Use (Describe)
Aloe Glide 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. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 21 CFR 201.2 Select B) | On The Counter Use (21 CFR 201.2 Select C) |
|---|---|
| ----------------------------------------------- | -------------------------------------------- |
_ | 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 Aloe Glide Lubricant - K190323
This summary uses the format provided in 21 CFR 807.92:
| (a)(1) Submitter/Owner: | Desert Harvest, Inc.
P.O. Box 1412 Hillsborough,
NC 27278 Phone: 919-245-
1853 |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Preparer/Contact: | Abhishek K. Gurnani
Amin Talati Wasserman, LLP
100 South Wacker Drive, Suite 2000
Chicago, IL 60606 |
| | Phone: 312-327-3325 |
| | Fax: 312-884-7352 |
| | Email: Abhishek@AminTalati.com |
| Summary Prepared: | September 24, 2019 |
| (a)(2) Trade Name: | Aloe Glide Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
-
(a)(3) Identification of Predicate Device: Aloe Cadabra Personal Lubricant (K124044).
The predicate device has not been subject to a design related recall. -
(a)(4) Device Description: Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, 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, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.
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Device specifications are listed in Table 1 below.
| Property | Specification |
|---|---|
| Appearance | Clear and transparent |
| Odor | Characteristic |
| Viscosity | 10,000 - 15,000 cps |
| Osmolality | 300 – 400 mOsm/kg |
| pH at 25 °C | 4.5 – 5.8 |
| Total Aerobic Microbial Count (USP | |
| ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli, Salmonella, Clostridium | |
| Species | Absent |
| Antimicrobial Effectiveness (USP) | |
| Escherichia coli, Pseudomonas | |
| aeruginosa, Staphylococcus aureus, | NLT a 2.0 log reduction from initial |
| count at 14 days and no increase from | |
| the 14 day count at 28 days | |
| Candida albicans, Aspergillus niger | No increase from the initial calculated |
| count at 14 and 28 days |
Table 1: Subject Device Specifications
- (a)(5) Indications for Use Statement: Aloe Glide 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. This product is not compatible with polyurethane condoms.
The subject and predicate device have the same intended use.
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(a)(6) Comparison of Technological Characteristics
| K190323 | K124044 | |
|---|---|---|
| Subject Device | Predicate | |
| Sponsor | Desert Harvest, Inc. | Seven Oaks Ranch, Inc. |
| Regulation Number | ||
| Product Code | ||
| Device Class | 844.5300 | |
| NUC | ||
| II | 844.5300 | |
| NUC | ||
| II | ||
| Indications for Use | Aloe Glide 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. This | ||
| product is not compatible with | ||
| polyurethane condoms. | Aloe Cadabra® Lubricant and | |
| Aloe Cadabra® | ||
| Flavored/Scented Lubricants | ||
| 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 and | ||
| polyisoprene condoms. This | ||
| product is | ||
| not compatible with | ||
| polyurethane condoms. | ||
| Physical Features | Clear liquid | Not known |
| Water-based | Yes | No (Aloe-based) |
| Primary | ||
| Ingredients | Water | |
| Xanthan Gum | ||
| Natapres* | Aloe Extract | |
| Sterile | No | No |
| Condom | ||
| Compatibility | Natural Rubber Latex | |
| Polyisoprene | Natural Rubber Latex | |
| Polyisoprene | ||
| Biocompatibility | ||
| Tested | Yes | Yes |
| Antimicrobial | ||
| Tested | Yes | Yes |
Table 2. Technological Characteristics of Aloe Glide and Compared to the Predicate
*Natapres contains glycerin, leuconostoc/radish, root ferment filtrate, lonicera japonica (honeysuckle) flower extract, lonicera caprifolium (honeysuckle) extract, populus tremuloides bark extract, and gluconolactone
6
The subject and predicate devices have the same indications for use statements. As noted in the table above, the subject and predicate device have different formulations. The 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: Aloe Glide 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 10993-11:2017. The testing found that Aloe Glide is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
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" 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: Aloe Glide has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can 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 Aloe Glide is as safe and effective as the predicate device and supports a determination of substantial equivalence