JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM

K982673 · Key West Fragrance & Cosmetic · HIS · Oct 29, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K982673
• Device Name: JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
• Applicant: Key West Fragrance & Cosmetic
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases .

Device Story

Convenience kit containing latex condom and water-soluble personal lubricant; lubricant formulated with purified water, glycerine, and Aloe Vera Gel. Intended for OTC use to enhance comfort during intimate activity. Lubricant is non-staining, odorless, and tasteless. Device functions by providing lubrication to reduce friction; compatible with latex condoms. Safety verified via ASTM D 3492-97 condom performance testing and ISO 10993-1 biological evaluation. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Condom performance tested per ASTM D 3492-97 to ensure lubricant does not compromise condom integrity. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Non-sterile convenience kit. Lubricant: water-soluble, glycerine and water-based, contains Aloe Vera Gel and Methylparaben. Packaging: plastic container. No energy source. No software. Complies with ASTM D 3492-97 for condom compatibility and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for individuals engaging in intimate activity to enhance comfort and ease; compatible with latex condoms for the reduction of risk of HIV and other sexually transmitted diseases.

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

• K-Y® Brand Liquid™ Personal Lubricant (K955648)
• WonderGel® Personal Liquid Gel (K903910)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

OCT 2 9 1998

Just Between Us™ Personal Lubricant & Condom submitted by Key West Fragrance & Cosmetic Factory, Inc. 524 Front Street Kev West. FL 33040 Phone: [phone] Facsimile: [phone]

#### Identification of a Legally Marketed Predicate Devices

The Personal Lubricant used in this convenience kit is substantially equivalent to the following legally manufactured and marketed devices.

- K-Y® Brand Liquid™ Personal Lubricant manufactured by Ortho Phar-● maceutical Corporation pursuant to 510(k) K955648
- WonderGel® Personal Liquid Gel manufactured by Lake Consumer Prod-. ucts. Inc. pursuant to 510(k) K903910

#### Device Description

The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package. The condom is legally manufactured and marketed pursuant to 510(k) K910550 by the London International Corporation. Key West Fragrance & Cosmetic Factory, Inc. will manufacture the personal lubricant. The personal lubricant is nonstaining, water-soluble, glycerine and water based lubricant containing Aloe Vera Gel.

#### Intended Use

The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.

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### Summary of Technological Characteristics

The table below compares the technological characteristics of the Just Between UsTM Personal Lubricant to the predicate devices.

| Feature | The Just Between<br>USTM | K-Y® Brand LiquidTM<br>Personal Lubricant | WonderGel® Per-<br>sonal Liquid Gel |
|------------------------------------|------------------------------------------------|-------------------------------------------|-------------------------------------|
| Manufacturer | Key West Fragrance &<br>Cosmetic Factory, Inc. | Ortho Pharmaceutical<br>Corporation | Lake Consumer Prod-<br>ucts, Inc. |
| Contains purified<br>water | Yes | Yes | Yes |
| Contains glycerine | Yes | Yes | Yes |
| Contains Aloe Vera<br>Gel | Yes | No | Yes |
| Contains Methyl-<br>paraben | Yes | Yes | Yes |
| Labeled Non-staining | Yes | Yes | Yes |
| Labeled odorless and<br>tasteless | Yes | No | Yes |
| Container Material | Plastic | Plastic | Plastic |
| Sterile | No | No | No |
| Labeled safe with<br>latex condoms | Yes | Yes | Yes |

### Summary of Performance Data

The Just Between Us™ Personal Lubricant was used to treat condoms that were subsequently tested in accordance with ASTM D 3492-97.4 The Just Between Us™ Personal Lubricant and Condom did not have a significant effect on the performance of the condom. The Just Between Us™ Personal Lubricant was tested and found to meet the in vivo test requirements of ISO 10993-1, Biological evaluation of medical devices-Part 1: Guidance on the selection of tests.

The Just Between Us™ Personal Lubricant and Condom is substantially equivalent to K-Y Brand Liquid™ Personal Lubricant manufactured by Ortho Pharmaceutical Corporation pursuant to 510(k) K955648 and WonderGel® Personal Liquid Gel manufactured by Lake Consumer Products, Inc. pursuant to 510(k) K903910.

Since the HPBT meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is

Key West Fragrance & Cosmetic Factory, Inc.

⁴ Standard Specification for Rubber Contraceptives (Male Condoms) American Society for Testing and Materials Designation D 3492-97 (1997)

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safe and effective and performs as well as or better than the predicate devices. The Just Between UsTM Personal Lubricant and Condom convenience kit will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & H. MA." arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1998

Mr. Joseph R. Liszka President Key West Fragrance & Cosmetic Factory, Inc. 524 Front Street Key West, FL 33040

Re: K982673

Just Between Us™, Personal Lubricant and Condom Dated: July 24, 1998 Received: July 31, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Liszka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmadsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use . . .

Page 1 of 1

510(k) Number (if known):

Device Name Just Between Us™ Personal Lubricant & Condom

Indications for Use:

The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.

If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases .

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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