MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS

K981955 · Ls Rubber Sdn Bhd · LTZ · Mar 15, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K981955
• Device Name: MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
• Applicant: Ls Rubber Sdn Bhd
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Device Story

Colored latex condom with spermicidal lubricant; intended for contraception and prevention of venereal disease transmission. Device functions as physical barrier; spermicide provides additional chemical protection. Used by consumers in over-the-counter setting. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data provided; device relies on established material safety and performance standards for latex condoms.

Technological Characteristics

Latex rubber condom; spermicidal lubricant; colored. Class II device per 21 CFR 884.5310. No electronic or software components.

Indications for Use

Indicated for contraception and prevention of venereal disease transmission in individuals seeking barrier protection.

Regulatory Classification

Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Mr. Mohamad Firdaos Mohamed Quality Assurance Manager LS Rubber SDN.BHD. PLO 22, Senai Industrial Estate Phase 1, 81400 Senai Johor, MALAYSIA

Re: K981955

Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms) Dated: December 10, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 884.5310/Procode: 85 LTZ

Dear Mr. Mohamed:

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 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). You may, therefore, market the device, subject to the general controls provisions of 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

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

## Page 2 - Mr. Mohamad Firdaos Mohamed

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.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Simist le. Nymm

\$\pi\$

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Page 1 of 1 . ________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K981955

Device Name: Colored and Spermicidal Lubricated Latex Condoms (Maxima, Trustex, Ria, and Premium El Les

Indications For Use:

The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use


(Optional Format 1-2-96)

David h. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dev 510(k) Number