MERCATOR HEALTHCARE MALE LATEX CONDOM

K031369 · Mercator Healthcare , Ltd. · HIS · Oct 31, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031369
• Device Name: MERCATOR HEALTHCARE MALE LATEX CONDOM
• Applicant: Mercator Healthcare , Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This latex condom has the same intended 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, including HIV.

Device Story

Male latex condom; natural rubber latex sheath; straight-walled with reservoir tip; nominal length 180-mm, width 52-mm, thickness 0.06mm. Lubricated with silicone; cornstarch dressing; smooth or textured (dotted/ribbed) surface. Used by individuals for contraception and STI prevention. Device provides physical barrier during intercourse.

Clinical Evidence

Bench testing only. Compliance with ASTM D3492 and ISO 4074 standards.

Technological Characteristics

Natural rubber latex sheath; straight-walled; reservoir tip; 180mm length, 52mm width, 0.06mm thickness. Silicone lubricant; cornstarch dressing. Conforms to ASTM D3492 and ISO 4074.

Indications for Use

Indicated for contraceptive and prophylactic purposes to help prevent pregnancy and the transmission 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.

Predicate Devices

• INDUS Male Condom (K993693)

Submission Summary (Full Text)

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## OCT 3 1 2003

K031369

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

## II. 510(k) SUMMARY

| Submitted By: | Anil J. Jain<br>Director of Operations<br>Mercator Healthcare Limited<br>83-87, Mittal Tower, B-Wing<br>Nariman Point, Mumbai MH 400 021<br>India |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eli J. Carter<br>Technical Consultant<br>1219 Little Creek Road<br>Durham, NC 27713 |
| Date Prepared: | April 28, 2003 |
| Proprietary Name: | Various Brand Names |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | INDUS Male Condom - K993693 |
| Description of Device: | This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. |
| Intended Use of the Device: | This latex condom has the same intended 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, including HIV. |
| Technological Characteristics: | This condom has the same technological characteristics as the predicate condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural |

rubber latex.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2003

Mercator Healthcare Limited % Mr. Eli J. Carter Technical Consultant 1219 Little Creek Road DURHAM NC 27713

Re: K031369

Trade Name/Device: Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: September 4, 2003 Received: September 9, 2003

Dear Mr. Carter:

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.

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

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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(i) 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §807.97). 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

David A. Leggman

for

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

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## INDICATIONS FOR USE STATEMENT VII.

| 510(k) Number | Not Known K031369 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Male Natural Rubber Latex Condom |
| Indications for Use: | The Mercator male latex condom is used for contraceptive and for<br>prophylactic purposes (to help prevent pregnancy and the transmission<br>of sexually transmitted diseases) |

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

Prescription Use OR Over-the-Counter Use 1 (Per 21 CFR 801.109)

David A. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number.