INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY

K970791 · Custom Services Intl., Inc. · LTZ · Jun 3, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970791
• Device Name: INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
• Applicant: Custom Services Intl., Inc.
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic. Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested." Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom

Device Story

ExtraWear™ is a lubricated latex male condom containing the spermicide Nonoxynol-9. Designed for over-the-counter use, it functions as a physical barrier to prevent the exchange of bodily fluids and as a chemical agent to reduce sperm activity. The device is intended to provide contraception and prophylaxis against disease. It is used by the patient during sexual activity. The device is marketed as having increased physical strength compared to the InnerWear™ predicate, though clinical breakage rates remain untested. The spermicidal component serves as a secondary measure to mitigate risk in the event of condom failure or improper use.

Clinical Evidence

Bench testing only. Laboratory tests of physical properties were conducted to compare the strength of the ExtraWear condom against the InnerWear predicate. No clinical data regarding breakage rates during sexual intercourse was provided.

Technological Characteristics

Material: Latex rubber. Lubricant: Nonoxynol-9 (spermicide). Form factor: Male condom. Energy source: None (mechanical barrier).

Indications for Use

Indicated for use by males as a contraceptive and prophylactic device to reduce the risk of pregnancy and sexually transmitted diseases.

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).

Predicate Devices

• InnerWear condom (K970791)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Ms. Lillie C. Thomas, M.S.
Executive Director of Quality Assurance
Custom Services International, Inc.
3111 West Post Road
Las Vegas, Nevada 89118

Re: K970791
ExtraWear™, Gentlemen’s Choice™, Extra Strength
Latex Condom with Nonoxynol-9
Dated: February 28, 1997
Received: March 4, 1997
Regulatory class: II
21 CFR §884.5310/Product code: 85 LTZ

Dear Ms. Thomas:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
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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MAY-29-1997 12:24
CS1 INC INNERWEA

510(k) Number: K970791

Device Name: Condom (rubber) Contraceptive 85-LTZ

Indications for Use:

Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.

Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."

Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom

Date Submitted: February 28, 1997

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970791

OR

Over-The-Counter Use ☑
(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)