PHARMAPAC LUBRICATING JELLY

K070623 · Pharmapac, LLC · NUC · Aug 31, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070623
• Device Name: PHARMAPAC LUBRICATING JELLY
• Applicant: Pharmapac, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

Device Story

PharmaPac Lubricating Jelly is a water-based personal lubricant; formulation includes chlorhexidine gluconate, methylparaben, glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. Device facilitates insertion of medical devices like rectal thermometers, enemas, and tampons; compatible with latex condoms. Used by consumers in home or clinical settings. Product provides lubrication to reduce friction during insertion or personal use.

Clinical Evidence

Bench testing only. Stability confirmed via accelerated stability study (90 days at 40°C / 75% R.H.) and parallel microbial study in accordance with USP standards to support a 24-month shelf life.

Technological Characteristics

Water-based lubricant. Ingredients: chlorhexidine gluconate, methylparaben, glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, purified water. Shelf life: 24 months. No electronic or software components.

Indications for Use

Indicated for personal lubrication and to facilitate the insertion of rectal thermometers, enemas, tampons, and similar nozzles. Compatible with latex condoms. For over-the-counter use.

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 Lubricating Jelly (K810310)

Submission Summary (Full Text)

{0}------------------------------------------------

K070623

# 510(k) Summary

| Submitter | PharmaPac, LLC<br>110 Industrial Park Road<br>DeKalb, MS 39328 | |
|---------------------|----------------------------------------------------------------|--------------|
| Contact Person | Tom Otto<br>[phone] phone<br>[phone] fax | AUG 3 1 2007 |
| Date Prepared | January 26, 2007 | |
| Proprietary Name | PharmaPac Lubricating Jelly Personal Lubricant | |
| Common Name | Personal Lubricant | |
| Classification Name | Patient Lubricant | |
| Predicate Device | K-Y® Brand Lubricating Jelly (K810310) | |

## Description of Device

PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

#### Intended Use

Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, tampons, and diagnostic or therapeutic devices. It is also compatible with latex condoms.

#### Technological Characteristics of Device Compared to Predicate

The technological characteristics of the PharmaPac Lubricating Jelly are identical to those of the predicate device.

## Performance Data

Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards

{1}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# AUG 3 1 2007

PharmaPac. LLC c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

K070623 Re:

> Trade Name: PharmaPac Lubricating Jelly Regulation Number: 21 CFR \$884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 16, 2007 Received: August 17, 2007

Dear Mr. Job:

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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. At the very bottom of the logo are three stars arranged horizontally. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.

toting and Promoting Publio Hodlio Hodlin

{2}------------------------------------------------

Enclosure

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C Hodgdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

#### Indications for Use

510(k) Number (if known): _ K070623

Device Name: _ PharmaPac Lubricating Jelly____________________________________________________________________________________________________________________________________

Indications for Use:

Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) +

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number