MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS

K980964 · Ls Rubber Sdn Bhd · HIS · Mar 12, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K980964
• Device Name: MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
• Applicant: Ls Rubber Sdn Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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

Device Story

Device consists of natural and colored latex condoms with flavored lubricant. Used for contraception and prevention of sexually transmitted diseases. Intended for over-the-counter use by individuals. Functions as a physical barrier to prevent exchange of bodily fluids during sexual intercourse. Benefits include pregnancy prevention and reduction of disease transmission risk.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Natural and colored latex rubber; lubricated with flavored lubricant; form factor is a sheath for the penis; regulated under 21 CFR 884.5300.

Indications for Use

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

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)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus-like symbol with three wavy lines representing the human services aspect of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

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

Re: K980964

.

Colored Latex Condom with Flavored Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms) Dated: December 10, 1998 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.5300/Procode: 85HIS

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 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.

{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 shelf life 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(i) 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 vours,

for

Daniel G. Schulttz, M.D.
CAPT

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): K980964

Natural and Colored Lubricated Latex Condoms with Flavors Device Name: (Maxima, Trustex, Ria, Premium and EL LES)

Indications For Use:

The intended use of these latex coloured condoms with flavour 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 \$\checkmark\$

(Optional Format 1-2-96)

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