SILICONE Personal Lubricant
Device Facts
| Record ID | K191654 |
|---|---|
| Device Name | SILICONE Personal Lubricant |
| Applicant | Bath Concept Cosmetics (Dongguan) Co., Ltd. |
| Product Code | NUC · Obstetrics/Gynecology |
| Decision Date | Apr 14, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
SILICONE Personal 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.
Device Story
SILICONE Personal Lubricant is a non-sterile, clear, odorless silicone-based gel (dimethicone and dimethiconol). Intended for over-the-counter use by adults to moisturize and lubricate during intimate sexual activity. Applied topically to penile and/or vaginal areas. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Device provides physical lubrication to reduce friction and enhance comfort. Packaged in 100 mL bottles. Safety and effectiveness established via bench testing, including biocompatibility (ISO 10993) and condom compatibility (ASTM D7661-10).
Clinical Evidence
No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), condom compatibility (ASTM D7661-10), and shelf-life stability (accelerated aging).
Technological Characteristics
Silicone-based gel (dimethicone, dimethiconol). Viscosity 300-700cps (USP <912>). Non-sterile. Biocompatibility per ISO 10993-5, -10, -11. Condom compatibility per ASTM D7661-10. Shelf life 18 months.
Indications for Use
Indicated for adult use as a personal lubricant for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; not compatible with 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
- ONE® SILICONE Personal Lubricant (K110690)
Submission Summary (Full Text)
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April 14, 2020
Bath Concept Cosmetics (Dongguan) Co., Ltd % Wei Zhang, Ph.D., RAC Regulatory Manager RGLM Consulting LLC 3302 171 St Pl SE Bathell, WA 98012
Re: K191654
> Trade/Device Name: SILICONE Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 10, 2020 Received: March 13, 2020
Dear Wei Zhang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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 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) K191654
Device Name SILICONE Personal Lubricant
#### Indications for Use (Describe)
SILICONE Personal 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 (Part 21 CFR 201, Subpart D) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Over-The-Counter (Part 21 CFR 201, Subpart G) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> |
__ 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 – K191654
# SILICONE Personal Lubricant
# A. General Information
| Submitter | Bath Concept Cosmetics (Dongguan) Co., Ltd<br>No.2, Dushang Industrial Zone, DaFen, WanJiang<br>District, Dongguan city, Guangdong, China |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person<br>(Preparer) | Wei Zhang, PhD RAC<br>RGLM consulting LLC<br>Regulatory Manager<br>Tel: 425-236-4274<br>Email: wei@rglm-fda.com |
| Date prepared | April 13, 2020 |
## B. Device
| Propriety Name | SILICONE Personal Lubricant |
|-------------------|-----------------------------|
| Common Name | Personal Lubricant |
| Product Code | NUC (Lubricant, Personal) |
| Regulatory Class | II |
| Regulation Number | 21 CFR §884.5300 |
| Regulation Name | Condom |
# C. Predicate Device
| Name | ONE® SILICONE Personal Lubricant |
|---------------|------------------------------------------|
| Owner | ONE®, 12 Channel Street Boston, MA 02210 |
| 510(k) number | K110690 |
The predicate device has not been subject to a design-related recall.
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### D. Description of the Device
SILICONE Personal Lubricant is a non-sterile, clear and odorless siliconebased personal lubricant for use during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. Its formulation consists of dimethicone and dimethiconol. The product is packed into a 3.38 oz (100 mL) bottle. Device specifications are listed in Table 1 below:
| Property | Specification |
|---------------------------------------------------|---------------|
| Appearance | Clear Gel |
| Color | Colorless |
| Odor | Odorless |
| Viscosity (@ 25°C) per USP <912> | 300-700cps |
| Total aerobic microbial count (TAMC) per USP <61> | < 10 CFU/g |
| Total yeast and mold count (TYMC) per USP <61> | < 10 CFU/g |
| Absence of Pathogens per USP <62> | |
| Escherichia coli | Absence |
| Pseudomonas aeruginosa | Absence |
| Staphylococcus aureus | Absence |
| Salmonella Enterica subsp. | Absence |
| Candida albicans | Absence |
| Clostridium sporogenes | Absence |
| Bile-tolerant Gram-negative Bacteria | Absence |
## Table 1. Subject Device Specifications
# E. Indications for Use
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SILICONE Personal 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.
| | Subject Device | Predicate Device |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | SILICONE Personal Lubricant | ONE® SILICONE Personal<br>Lubricant |
| Sponsor | Bath Concept Cosmetics<br>(Dongguan) Co., Ltd | ONE® |
| 510(k) number | K191654 | K110690 |
| Regulation No. | 21 CFR §884.5300 | 21 CFR §884.5300 |
| Product Code | NUC | NUC |
| Class | II | II |
| Intended use | SILICONE Personal Lubricant<br>is an over-the-counter personal<br>lubricant. | ONE® SILICONE Personal<br>Lubricant is an over-the-<br>counter personal lubricant. |
| Indications for<br>Use | SILICONE Personal Lubricant<br>is a personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort<br>of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber | ONE® SILICONE Personal<br>Lubricant is a personal<br>lubricant, for penile and/or<br>vaginal application, intended<br>to moisturize and lubricate, to<br>enhance the ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>This product is compatible |
| | latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | with natural rubber latex,<br>polyisoprene, and<br>polyurethane condoms. |
| OTC use? | Yes | Yes |
| Primary<br>ingredients | Dimethicone<br>Dimethiconol | Dimethicone<br>Dimethiconol |
| Targeted<br>population | Adult | Adult |
| Appearance | Clear | Clear |
| Color | Colorless | Colorless |
| Odor | No Odor | No Odor |
| Viscosity (25°C) | 300-700cps | 300-400 cps |
| Total aerobic<br>microbial count<br>(TAMC) | < 10 CFU/g | < 10 CFU/g |
| Total yeast and<br>mold count<br>(TYMC) | < 10 CFU/g | < 10 CFU/g |
| Absence of<br>pathogenic<br>organisms | Absence | Not provided |
| Application site | Penile and/or vaginal | Penile and/or vaginal |
| Condom<br>Compatibility | Natural Rubber Latex and<br>Polyisoprene | Natural Rubber Latex,<br>Polyurethane, and<br>Polyisoprene |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility<br>Tests | Comply with ISO 10993<br>biocompatibility evaluation | Comply with ISO 10993<br>biocompatibility evaluation |
# F. Comparison of Intended Use and Technological Characteristics to the Predicate Device
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| Shelf Life | 1 year & 6 months (18 months) | 1 year (12 months) |
|------------|-------------------------------|--------------------|
|------------|-------------------------------|--------------------|
The subject product and the predicate device have similar indications for use statements and have the same Intended Use.
The subject and predicate device have different technological characteristics, including different shelf-life and condom compatibility. The differences in technological characteristics described above between the subject and predicate device do not raise different questions of safety and effectiveness.
### G. Summary of non-clinical performance testing:
#### Shelf life
SILICONE Personal Lubricant has a one-year-and-six-month (18 months) shelf life based on the results of an accelerated aging study. The results of the shelf life study demonstrated that the subject device met all device specifications at baseline and throughout the proposed shelf life.
### Condom Compatibility
The compatibility of the SILICONE Personal Lubricant with male condoms was tested in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Condom compatibility testing was performed with three different brands of natural rubber latex, one brand of polyisoprene, and one brand of polyurethane condoms. The results indicate that SILICONE Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
### Biocompatibility
The biocompatibility evaluation for the SILICONE Personal Lubricant was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 2016, and
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International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The evaluation included the following tests:
- Cytotoxicity (ISO 10993-5:2009) .
- Sensitization (ISO 10993-10:2010) .
- Vaginal Irritation (ISO 10993-10:2010) .
- Acute Systemic Toxicity (ISO 10993-11:2017) .
The results of this testing demonstrated that the subject lubricant is noncytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
# H. Conclusions
The results of the performance testing described above demonstrate that the SILICONE personal lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
