MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

K990925 · Hardcover Products, Inc. · HIS · Jun 17, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990925
• Device Name: MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
• Applicant: Hardcover Products, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jun 17, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

Device Story

HardCover Condoms are male latex condoms intended for contraception and prophylaxis against sexually transmitted diseases and HIV. Used by individuals in an over-the-counter setting. Device acts 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; bench testing only.

Technological Characteristics

Male latex condom; physical barrier device. Complies with 21 CFR 884.5300 and 801.435 regarding expiration dating and labeling requirements.

Indications for Use

Indicated for use by individuals for contraception and the prevention of pregnancy and sexually transmitted diseases, including HIV (AIDS).

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with its wings forming a flowing, abstract shape. Encircling the bird symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1999

Mr. Gerald A. Glazer, CA President HardCover Products Inc. TM 55 Administration Road, Unit 12 Concord, Ontario Canada, L4K 4G9

Re: K990925

HardCover Condoms™ Male Latex Condoms Dated: March 1, 1999 Received: March 19, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS

Dear Mr. Glazer:

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.

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

Page 2 - Mr. Gerald A. Glazer, CA

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

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 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,

Urrich br. Beynon

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}------------------------------------------------

510(12) HARD COUT

Indications for Use: These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

## (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

David A. Beyer
(Division Sign-Off)

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

8