Gun Oil, Pink, Gun Oil H2O, Pink Water

K152918 · Empowered Products, Inc. · NUC · Jun 2, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K152918
• Device Name: Gun Oil, Pink, Gun Oil H2O, Pink Water
• Applicant: Empowered Products, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms. Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms. Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms. Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

Device Story

Personal lubricants (silicone-based and water-based) designed to moisturize and lubricate during intimate sexual activity. Applied topically by the user to enhance comfort. Products are formulated for compatibility with specific condom materials (polyurethane or polyisoprene) to prevent condom degradation. Used in home settings by consumers. Benefits include reduced friction and increased comfort during sexual intercourse.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Personal lubricants formulated as either silicone-based or water-based. Products are chemically engineered for compatibility with specific condom materials (polyurethane or polyisoprene).

Indications for Use

Indicated for individuals engaging in intimate sexual activity requiring moisturization and lubrication to enhance ease and comfort. Compatible with specific condom types (polyurethane or polyisoprene) depending on the specific lubricant formulation; contraindicated for use with incompatible condom materials (natural rubber latex and others as specified per product).

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2016

Empowered Products, Inc. % Judy Burton President Advena Usa, LLC 3010 LBJ Frwy., 12th Floor Dallas, TX 75234

Re: K152918

Trade/Device Name: Gun Oil, Pink, Gun Oil H2o, Pink Water Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 21, 2016 Received: May 6, 2016

Dear Judy Burton,

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known) K152918

#### Device Name

Gun Oil silicone lubricant, Pink silicone lubricant for Women, Gun Oil H20 water-based lubricant for Women

#### Indications for Use (Describe)

Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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