CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH

K970767 · Custom Services Intl., Inc. · HIS · Jun 2, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970767
• Device Name: CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
• Applicant: Custom Services Intl., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jun 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.

Device Story

ExtraWear, Gentlemen’s Choice, and Extra Strength lubricated latex condoms are male contraceptive devices. Designed for over-the-counter use, these devices function as a physical barrier to prevent pregnancy and the transmission of sexually transmitted diseases. The device is a rubber sheath worn during intercourse. Clinical benefit is derived from its barrier properties. The manufacturer claims increased strength compared to the InnerWear condom based on laboratory physical property testing.

Clinical Evidence

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

Technological Characteristics

Material: Latex rubber. Form factor: Male sheath. Lubricated. Intended for over-the-counter use. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for use by males as a contraceptive and prophylactic to prevent pregnancy and reduce the risk of 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.

Reference Devices

• InnerWear condom

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

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

Re: K970767
ExtraWear™, Gentlemen’s Choice™, Extra Strength
Lubricated Latex Condom
Dated: February 28, 1997
Received: March 3, 1997
Regulatory class: II
21 CFR §884.5300/Product code: 85 HIS

JUN - 2 1997

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 12:23
Page 1 of 1

510(k) Number: K970767

Device Name: Condom (rubber) Contraceptive 85-HIS

Indications for Use:

Extra Strength lubricated rubber male condom 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."

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 K970767

Prescription Use
(Per 21 CFR 801.109)

OR

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