RICHTER MALE LATEX CONDOM

K070511 · Richter Rubber Technology Sbn Bhd · HIS · Jan 14, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K070511
• Device Name: RICHTER MALE LATEX CONDOM
• Applicant: Richter Rubber Technology Sbn Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jan 14, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Natural rubber latex sheath; straight-walled with reservoir tip; silicone lubricated; colorless, flavorless, unscented. Covers erect penis as closely fitted membrane. Used for contraception and prophylaxis against pregnancy and STDs. Intended for over-the-counter use by individuals.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and conformance to established standards (ASTM D3492 and ISO 4074).

Technological Characteristics

Natural rubber latex sheath; silicone lubricant (250 cps); cornstarch dressing. Dimensions: 185 mm length, 54 mm width, 0.07 mm thickness. Design conforms to ASTM D3492 and ISO 4074 standards.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases (including HIV) in individuals using male condoms.

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

• UNIDUS Male Latex Condom (K023059)

Submission Summary (Full Text)

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JAN 1 4 2008

# Kd7 4511

## Abbreviated 510 (k) Notification for a Male Latex Condom

Page 5 of 13

### I. 510(k) SUMMARY

| Submitted By: | Richter Rubber Technology SBN BHD<br>Plot 33, Kuala Ketil Industrial Estate<br>09300 Kuala Ketil, Kedah<br>Malaysia |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eli J. Carter, Consultant<br>PO Box 12139<br>Durham, NC 27709<br>Tel: [phone]; Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 26, 2007 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom: 54 mm (nominal width), 185 mm (nominal<br>length), straight-wall with reservoir tip, silicone lubricated, colorless,<br>flavorless, unscented |
| Classification Name: | Male Latex Condom |
| Predicate Devices: | UNIDUS Male Latex Condom - K023059 |
| Description of Device: | This condom is made of a natural rubber latex sheath, which<br>completely covers the erect penis with a closely fitted membrane. This<br>condom is colorless, non flavored, non scented; straight walled with a<br>reservoir tip. The nominal length is 185 mm, nominal width, 54 mm<br>and nominal thickness 0.07mm. It is lubricated with silicone (viscosity<br>250 cps), and cornstarch is used as a dressing material. This condom<br>conforms to current established national and international voluntary<br>standards including ASTM D3492 and ISO 4074. |
| Intended Use of the Device: | This latex condom has the same intended use as the predicate condom.<br>The condom is used for contraception and for prophylactic purposes to<br>help prevent pregnancy and the transmission of sexually transmitted<br>diseases, including HIV. |

User Instructions and Precautions are provided to insure proper
use and disposal of the product after use. See Package Labeling
and Insert - (Attachment 2).

| Technological Characteristics: | This condom has the same technological characteristics as the predicate<br>condoms identified above. It is made from natural rubber latex and |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|

the design is in conformance with ASTM D3492 and ISO 4074 Male

Latex Condom Standards.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richter Rubber Technology SBN BHD % Eli J. Carter, Ph.D. Consultant Family Health International P.O. Box 12139 DURHAM NC 27709

Re: K070511

Trade/Device Name: Richter Male Latex Condom: 54 mm (nominal width), 185 mm (nominal length), straight-wall with reservoir tip, silicone lubricated, colorless, flavorless, unscented

Regulation Number: 21 CFR 884.5300

Regulation Name: Condom

Regulatory Class: II Product Code: HIS

Product Code. 115

Dated: December 26, 2007 Received: December 31, 2007

## Dear Dr. Carter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Information for a Male Latex Condom 510(k) Submission

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#### II. INDICATIONS FOR USE STATEMENT

:

| 510(k) Number: | K070511 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Richter Male Latex Condom<br>54mm (nominal width), 185 mm (nominal length), straight-wall<br>with reservoir tip, silicone lubricated, colorless, flavorless,<br>unscented |
| Indications for Use: | The Richter Male Latex Condom is used for contraception and for<br>prophylactic purposes (to help prevent pregnancy and the transmission<br>of sexually transmitted diseases) |

.

の 2007年 10月 2007 10:00 PM 100 100 100 100 100 100

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | | |
|------------------------------------------|-------------------------|--|
| | OR Over-the-Counter Use | |
| (Division Sign-Off) | | |