DUREX SENSIDOM LATEX CONDOM

K982924 · London Intl., LLC · HIS · Nov 16, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K982924
• Device Name: DUREX SENSIDOM LATEX CONDOM
• Applicant: London Intl., LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Durex Sensidom is a natural rubber latex sheath designed to cover the penis; nipple-ended; 52mm width, 160mm length, 0.03mm thickness. Used for contraception and prevention of sexually transmitted diseases. Device is an over-the-counter product for consumer use. Operates as a physical barrier. Differs from predicate only by use of an alternative non-spermicidal lubricant.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and physical property comparisons to the predicate device.

Technological Characteristics

Natural rubber latex sheath; nipple-ended; 52mm width, 160mm length, 0.03mm thickness. Conforms to ASTM D3492. Non-spermicidal lubricant.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals using 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

• Latex Lubricated Condom (K952415)

Submission Summary (Full Text)

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K982924

NOV 1 6 1998

#### II. 510(K) SUMMARY

| Submitted By: | London International Group<br>P.O. Box 8308<br>2926 Columbia Highway<br>Dothan, AL 36304 | |
|----------------------|------------------------------------------------------------------------------------------|--|
| | Phone: [phone] | |
| Contact Person: | Neil Anderson, RAC<br>Director of Regulatory Affairs for U.S. Operations | |
| Date Prepared: | | |
| Proprietary Name: | Durex Sensidom Male Latex Condom | |
| Common Name: | Latex Condom | |
| Classification Name: | Condom (21 CFR Section 844.5300) | |
| Predicate Device: | Latex Lubricated Condom<br>510(k) K952415 | |

Description of the Device

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This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of

| Width: | 52 mm |
|------------|--------------|
| Length: | 160 mm min. |
| Thickness: | 0.03 mm min. |

## Intended Use of the Device

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

# Technological Characteristics

The condom has the same technological characteristics as the predicate device identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and is made of natural rubber latex.

It has the same dimensions, the same physical properties, is manufactured on identical manufacturing equipment utilizing the same raw materials and formulation.

The same Quality Program is in effect.

The only difference with this device to the predicate is the substitution of an alternative lubricant (non-spermicidal).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 16 1998

Neil Anderson, RAC Director of Regulatory Affairs, U.S. Operations London International Group (LIG) P.O. Box 8308 2926 Columbia Highway Dothan, Alabama 36304

Re: K982924

Durex® Sensidom Latex Rubber Condoms Regulatory Class: II 21 CFR 884.5300 Product Code: 85 HIS Dated: August 18, 1998 Received: August 20, 1998

Dear Mr. Anderson:

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.

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 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.

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Page 1 - Mr. Neil Anderson

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.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with User 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 Assistance at its tollfree number [phone] or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Lillian Yin, Ph.D.

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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## APPENDIX IV

Page 1 of 1

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

s

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

(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 | K982924 |

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use V

(Optional Format 1-2-96)