EXTRAWEAR, GENTLEMEN'S CHOICE

K972428 · Custom Services Intl., Inc. · HIS · Aug 25, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K972428
• Device Name: EXTRAWEAR, GENTLEMEN'S CHOICE
• Applicant: Custom Services Intl., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

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

Device Story

Latex rubber male condom; Type I, Style 2, Class A per ASTM 3492-93. Designed for contraception and prevention of sexually transmitted diseases (including HIV). Features extra strength and added FDA-certified color; available in lubricated (silicone) or nonlubricated versions. Used by consumers in home/personal settings. Provides physical barrier; intended to reduce risk of pregnancy and disease transmission.

Clinical Evidence

Bench testing only. Physical property testing performed to verify extra strength characteristics. No clinical data regarding breakage rates during use provided.

Technological Characteristics

Latex rubber; Type I, Style 2, Class A per ASTM 3492-93; ISO 4074-6. Dimensions: approx. 180 mm length, 52 mm width. Lubricated with silicone or nonlubricated. Includes FDA-certified colorants. Mechanical barrier device.

Indications for Use

Indicated for use by males as a contraceptive and for protection against sexually transmitted diseases, including HIV.

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

• Custom Services International Inc. K970767 (lubricated)
• Custom Services International Inc. K970792 (nonlubricated)

Submission Summary (Full Text)

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## K972428

## 510(k) Summarv Notification

| Submitter: | Custom Services International, Inc.<br>3111 Post Rd.<br>Las Vegas, NV 89118 | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Telephone Number: | [phone] | AUG 25 1997 |
| Contact: | Lillie C. Thomas, M.S.<br>Executive Director of Quality Assurance | |
| Registration Number: | 2951584 | |
| Date Submitted: | June 26, 1997 | |
| Name of the Device: | Condom, smooth surface, reservoir end, approximately 180 mm in<br>length and 52 mm in width (Type 1, Style 2, Class A) rubber<br>contraceptive device, lubricated with silicone or nonlubricated,<br>extra strength and colored. | |
| Trade Names: | ExtraWear TM, Gentlemen's ChoiceTM | |
| Equivalent Device: | Custom Services International Inc. Application K970767<br>(lubricated) and K970792 (nonlubricated) found to<br>be substantially equivalent on June 2, 1997 (Type 1, Style 2,<br>Class A) rubber contraceptive device, lubricated with silicone or<br>nonlubricated, tested to a higher quality standard for added strength<br>and colored. | |
| Class of Device: | Class II, Condom (rubber) Contraceptive - 85HIS | |

## Description of Device Covered by this Submission

The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-HIS") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards can be lubricated or nonlubricated, and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970767 and K970792 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.

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Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The logo is black and white and appears to be a scan or photocopy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K972428 ExtraWear™, Gentlemen's Choice™ Dated: June 26, 1997 Received: June 27, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS

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, 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.

AUG 25 1997

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 requirement, 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 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,

W. Niau Yu

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

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Page 1 of D

510(k) Number:

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: June 26, 1997

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div></div> <div>(Division Sign-Off)</div> |
|---------------|--------------------------------------------------------------------|
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K972428 |

| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|--------------------------------------|----|-----------------------------------------------|
|--------------------------------------|----|-----------------------------------------------|

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510(k) Number:

## Condom (rubber) Contraceptive 85-HIS Device Name:

Indications for Use:

Extra strength nonlubricated 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:

June 26, 1997

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center">Rater R Sathi</div> <div align="center">(Division Sign-Off)</div> |
|--|---------------------------------------------------------------------------------------|
|--|---------------------------------------------------------------------------------------|

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K97248 |
|---------------|--------|
|---------------|--------|

| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-The-Counter Use |
|-----------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |