DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM

K040185 · Ssl Americas · HIS · Apr 27, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040185
• Device Name: DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
• Applicant: Ssl Americas
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Device is a parallel-sided, teat-ended, lubricated natural rubber latex sheath designed to cover the penis. Features raised studs and ribs on the surface. Used by individuals for contraception and prevention of sexually transmitted diseases. Device functions as a physical barrier. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. Device conforms to ASTM D3492, ISO 10993, and ISO 4074:2002 standards. Physical and final release testing confirmed conformance with required specifications.

Technological Characteristics

Natural rubber latex sheath; parallel-sided, teat-ended, lubricated. Features raised studs and ribs. Conforms to ASTM D3492, ISO 10993, ISO 4074, and EN 600 standards. No electronic components or software.

Indications for Use

Indicated for contraception and prophylaxis against sexually transmitted diseases in individuals seeking barrier protection.

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

• Dotted Condom Ribbed Condoms (K902509)
• Durex Latex Rubber Condom (K980319)

Submission Summary (Full Text)

{0}------------------------------------------------

Durex studded/ribbed Latex Condom Premarket approval [510(k)]

### Section | General Information

#### Name and address of applicant বে

SSL Americas 3585 Engineering Drive, Norcross, GA 30092-9214. The general phone number for SSL Americas is 770-582-2222, fax number is 770-582-2204.

#### B. Contact Person

Chris Robinson Controller - Head of Global Regulatory Affairs, SSL Americas Phone: [phone] Fax: [phone] Email: [e-mail]

#### C. Establishment Registration of Submitter 1065445

#### Name and address of SSL manufacturing facility a

TTK-LIG LTD. Located at: 35 Old Trunk Rd., Pallavaram, Chennai, India 600 043 Establishment registration number: 3003878048.

TTK-LIG LTD Located at: 20 Perali Road, Virudhungar, India 626 001 Establishment registration number: 9680394

#### Name of Device uj

Proprietary Name: Durex studded/ribbed lubricated Latex Condom (commercial name Pleasuremax Condom) Common Name: Male Latex Condom Classification Name: Condom (21 CFR 884.5300)

#### Classification of Device ি.

Class II Condom 21 CFR 884.5300

#### G. Action Taken to Comply with Section 514 of the Act

The Durex latex condoms conforms to the ASTM D3492 , ISO 10993 and ISO 4074:2002 standards, except were variances are noted. Conformance to these standards is described on the following pages.

Page 6 of 23

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

Image /page/1/Picture/0 description: The image shows the logo for SSL Americas, Inc. The logo is black and white and features the letters "SSL" in large font, followed by "Americas, Inc." in a smaller font. There is a black curved line above the letters and below the letters. The words "Durex studded and" are also visible in a smaller font below "Americas, Inc."

Office of Requlatory Affairs

and ribbed Male Latex Condom Prematfil&fingineering Dire, Suite 200 Norcross, GA 30092-9214

approval [510(k)]

Tel: [phone] Fax: [phone]

# Section II Summary

#### Submitter Information বে

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233

### B. Contact Person

Kathleen Harris, Requlatory Affairs Manager, SSL Americas

C. Date Prepared January 14, 2004

# D. Proprietary Name

Durex studded and ribbed Male Latex Condom Trade name to be determined later

# E. Common Name

Male Latex Condom

# F. Classification Name

માટ

# G. Predicated Device

Dotted Condom Ribbed Condoms [510(k) Number K902509] Durex Latex Rubber Condom [510(k) Number K980319]

# H. Description of the Device

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, lubricated condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492.

Image /page/1/Picture/22 description: The image shows a black rectangle with the word "REGENT" in white text at the top. Below the word "REGENT" are five horizontal white lines of decreasing length, resembling a simple graphic or logo. The background is solid black, providing a high contrast for the white text and lines.

{2}------------------------------------------------

# Durex studded and ribbed Male Latex Condom Premarket approval [510(k)]

### I. Intended Use of the Device

This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

#### J. Technological Characteristics

This condom has the same technological characteristics as the predicate condoms identified. The condoms described in K012962 are manufactured of natural rubber latex with raised studs. The condoms described in K902509 are Durex manufactured ribbed Natural Rubber Latex male condoms with silicone lubricant. The condoms described in K980319 are Durex manufactured natural rubber latex male condoms with silicone lubricant. The condom design conforms to domestic and international regulations: ASTM D3942. ISO 4074 and EN 600. All physical testing and final release testing revealed results in conformance with required specifications.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 7 2004

Mr. Chris Robinson Controller – Head of Global Regulatory Affairs SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K040185

Trade/Device Name: Durex Pleasuremax Condom - Male latex condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 20, 2004 Received: January 28, 2004

Dear Mr. Robinson:

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.

Your device is classified (see above) into class II (Special Controls) and is 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.

{4}------------------------------------------------

Page 2 - Mr. Chris Robinson

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(j) 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 product 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, International and Consumer Assistance at its toll-free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.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

{5}------------------------------------------------

0 3/63

| Indications for Use | |
|---------------------|--|
|---------------------|--|

K 040185

| 510(k) Number (if known): | |
|---------------------------|--|
|---------------------------|--|

Pleasuremax

| Device Name: | Durex Mutual Pleasure condom |
|--------------|------------------------------|
|--------------|------------------------------|

Indications For Use: Durex latex condom is used for contraception and for pIndications For Use: Durex latex condom is used for contraception and for prophylactic maloutions For Soon a see and the transmission of sexually transmitted disease).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Image /page/5/Picture/6 description: The image shows the words "Counter Use" with a line underneath and a check mark above the line. The words "7 Subpart C" are below the words "Counter Use". The check mark is made up of two lines that cross each other.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

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

Page 1 of __ 1__