LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT

K974323 · Reddy Medtech Health Products , Ltd. · HIS · Feb 10, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974323
• Device Name: LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
• Applicant: Reddy Medtech Health Products , Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Device Story

Latex condom with silicone oil lubricant; intended for vaginal intercourse. Acts as physical barrier to prevent pregnancy and reduce transmission of HIV and other sexually transmitted diseases. Used by consumers in non-clinical settings. Effectiveness dependent on proper usage per package instructions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural latex rubber sheath; silicone oil lubricant. Form factor: standard condom. Class II device (21 CFR 884.5300).

Indications for Use

Indicated for use by individuals to prevent pregnancy and reduce the risk of transmission of HIV (AIDS) and other sexually transmitted diseases (chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis) during vaginal intercourse.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo is a stylized eagle with three lines representing the wings and body. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Ravi Reddy President Reddy Medtech Health Products, Ltd. 9 Webster Court Plainsbora, NJ 08536

Re: K974323

Latex Condoms, Natural Color with Silicone Oil Lubricant Dated: November 7, 1997 Received: November 18, 1997 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Reddy:

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 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 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 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 OS 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 yitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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,

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

Enclosure

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K974323/A2

Page 1 of 1

510(k) NUMBER (IF KNOWN): K 9743 Z3

DEVICE NAME:

INDICATIONS FOR USE:

If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format 1-2-96)

Roler Ralling/

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974323