ANSELL CONDOMS

K984392 · Ansell, Inc. · HIS · Jul 21, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K984392
• Device Name: ANSELL CONDOMS
• Applicant: Ansell, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jul 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. If used properly, these condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, these condoms will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condoms should be applied before any such contact.

Device Story

Ansell condoms are natural rubber latex sheaths designed for male contraception and prophylaxis. Each device features an integral ring at the open end and a reservoir at the closed end to contain semen. Used by individuals during sexual intercourse, the device acts as a physical barrier to reduce the risk of pregnancy and the transmission of sexually transmitted diseases, including HIV. The device is applied manually by the user before intimate contact. Effectiveness relies on proper usage as directed.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on adherence to established material and manufacturing standards for latex condoms.

Technological Characteristics

Natural rubber latex sheath; integral ring at open end; reservoir at closed end. Conforms to ASTM D 3492, ISO 4074, and EN 600 standards. Non-electronic, mechanical barrier device.

Indications for Use

Indicated for use by males as a contraceptive and prophylactic device to cover the penis during sexual intercourse, helping to reduce the risk of pregnancy and the transmission 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

• Male Latex Condoms

Submission Summary (Full Text)

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JUL 2 1 1999

CONFIDENTIAL

### ANSELL CONDOMS

### Summary of Safety and Effectiveness

Submitter:

Ansell Incorporated 1500 Industrial Road Post Office Box 1252 Dothan, Alabama 36302 Phone: (334) 794 - 4231 Fax: (334) 792 - 8485

Date summary was prepared:

November 25, 1998

Name(s) of the device:

Ansell Condoms

Identification of predicate device(s):

Male Latex Condoms

Description of the device:

Ansell condoms are male contraceptive and prophylactic devices, which are fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. Ansell condoms are designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600.

#### Intended Use:

Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. If used properly, these condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, these condoms will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed,

December 4, 1998 Ansell Condoms

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may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condoms should be applied before any such contact.

# Comparison of device characteristics to predicate:

The indications for use for the line of condoms covered by this 510(k) are the same as predicate male latex condoms. The design and manufacture of these condoms are the same as predicate male latex condoms. Therefore, this line of condoms is substantially equivalent.

# Conclusion:

Because the condom materials and manufacturing processes conform to domestic and international regulations, no new safety and effectiveness issues are expected to be raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 1999

Mr. Lon D. McIlvain Quality Assurance/Regulatory Manager Ansell Incorporated 1500 Industrial Road P.O. Box 1252 Dothan, Alabama 36302

Re: K984392

Male Latex Condoms - Repackaging of Outsourced Condoms Dated: April 21, 1999 Received: April 22, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS 21 CFR §884.5310/Procode: 85 LTZ

Dear Mr. McIlvain:

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 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 (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

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Page 2 - Mr. Lon D. McIlvain

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

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(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 products 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.

Sincerely yours,

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number:

None assigned as of this time

Ansell Condoms Device Name:

#### Indications for Use:

The LifeStyles Xtra Pleasure condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (per 21 CFR 801.109)

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Over-the Counter Use

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

December 4, 1998 Ansell Condoms