(169 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, intended use, and packaging. There is no mention of any computational or analytical functions that would require AI/ML.
No
This device is a personal lubricant intended to enhance comfort during sexual activity and supplement natural lubrication, not to treat or diagnose a medical condition.
No
Explanation: The "Intended Use" section clearly states that the product is a lubricant intended to "lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This function is for enhancing comfort and facilitating an activity, not for diagnosing a medical condition.
No
The device is a physical product (silicone lubricant) and not software. The description details the physical form, packaging, and compatibility with condoms, which are all hardware/material characteristics.
Based on the provided information, 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, anal, and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the lubricant (clear, thin, liquid) and its packaging. There is no mention of it being used to test or diagnose any condition.
- Performance Studies: The performance studies described (biocompatibility, shelf-life, condom compatibility) are relevant to the safety and efficacy of a personal lubricant, not an IVD. IVD performance studies would typically involve evaluating the accuracy and reliability of a test to detect a specific analyte or condition.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.) or performing any kind of test or analysis to provide diagnostic information.
In summary, the device is a personal lubricant intended for physical application and lubrication, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are silicone-based personal lubricants 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.
Product codes
NUC
Device Description
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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.
The Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.
#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal 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)
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2016 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" and ISO 10993-1:2009.
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
Results: The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, and non-sensitizing, and non-systemically toxic.
Shelf-Life:
The subject device is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of real time and accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap and bottles with pump closure. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life. The subject device specifications at all time points.
Condom Compatibility:
The compatibility of the subject device 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.
Results: The results of this test indicated that Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 18, 2019
United Consortium Marlent Perez Quality Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K190858
Trade/Device Name: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 15, 2019 Received: August 19, 2019
Dear Marlent Perez:
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.
1
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.
for Sharon 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190858
Device Name
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
Indications for Use (Describe)
Bucked Stride Silicone Lubricant is a silicone-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.
#LubeLife Thin Silicone Lubricant is a silicone-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.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for pende, 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.
| 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) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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3
510 (k) Summary - K190858
1. Submitter Information
| Applicant: | United Consortium |
|---|---|
| Contact: | Marlent Perez |
| Quality Specialist | |
| Bruce Albert | |
| Head of Technical Services | |
| Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Phone: | (661) 295-1700, ext. 1007 |
| FAX: | (661) 295-1800 |
2. Correspondent Information
| Contact: | Marlent Perez |
|---|---|
| Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Phone: | (661) 295-1700, ext. 1007 |
| Fax: | (661) 295-1800 |
| Email: | mperez@systemjo.com |
3. Date prepared: September 16, 2019
4. Device Information
Device Name:
| | Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal
Lubricant |
|--------------------|-----------------------------------------------------------------------|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone
5. Predicate Device Information
| Device Name: | Silicone Personal Lubricant, ALL-IN-ONE |
|---|---|
| 510(k) Number: | K180083 |
| Manufacturer: | United Consortium |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
6. Device Description
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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.
4
The Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.
#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
The device specifications are listed in the table below :
Table 1: Device Specifications for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
| Property | Specification |
|---|---|
| Appearance | Clear, thin liquid |
| Color | Clear, colorless |
| Odor | Odorless |
| Viscosity (cps) | 200 to 325 cps |
| Specific Gravity | 0.850 to 1.025 |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for |
| Category 2 products | |
| Total aerobic microbial count (TAMC) per | |
| USP and | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per | |
| USP and | Less than 10 cfu/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
7. Indications for Use
Bucked Stride Silicone Lubricant is a silicone-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.
#LubeLife Thin Silicone Lubricant is a silicone-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.
5
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-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.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below lists the a comparison of the indications for use and technological characteristics of the subject and predicate device.
| | Bucked Stride Silicone
Lubricant #LubeLife Thin
Silicone Lubricant
JO XTRA SILKY Ultra-
Thin Silicone Personal
Lubricant | Silicone Personal
Lubricant, ALL-IN-
ONE
(K180083) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Bucked Stride Silicone Lubricant
is a silicone-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.
#LubeLife Thin Silicone
Lubricant is a silicone-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. | Silicone Personal Lubricant is a
silicone- 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, polyurethane and
polyisoprene condoms.
ALL-IN-ONE is a silicone-
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,
polyurethane and
polyisoprene condoms. |
Table 2: Comparator Table for Subject Device - Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant and Predicate Device Silicone Personal Lubricant, ALL-IN-ONE
6
| Feature | Bucked Stride Silicone
Lubricant #Lube Life Thin
Silicone Lubricant
JO XTRA SILKY Ultra-
Thin Silicone Personal
Lubricant | Silicone Personal
Lubricant, ALL-IN-
ONE
(K180083) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Water soluble | No | No |
| Contains water | No | No |
| Primary ingredients | Dimethicone, Dimethiconol,
Tocopheryl (Vitamin E) Acetate | Dimethicone, Dimethiconol |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex,
Polyisoprene | Natural Rubber Latex,
Polyisoprene, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 years | 2 years |
The subject and predicate device have similar indications for use and have the same intended use. The subject and predicate device have similar technological characteristics, including similar formulation and shelf-life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2016 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" and ISO 10993-1:2009 as follows:
- . Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010)
7
- Penile Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2006) ●
The results of this testing demonstrated that the subject lubricant isnon-cytotoxic, non-irritating, and nonsensitizing, and non-systemically toxic ..
Shelf-Life
The subject device is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of real time and accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap and bottles with pump closure. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life. The subject device specifications at all time points.
Condom Compatibility
The compatibility of the subject device 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. The results of this test indicated that Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
10. Conclusion
The results of the performance testing described above demonstrate that the Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are as safe and effective as the predicate device and supports a determination of substantial equivalence.