DOUBLE SPRINGERS NONOXNOL 9 CONDOM

K012969 · Medtech Products , Ltd. · LTZ · Jun 12, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K012969
• Device Name: DOUBLE SPRINGERS NONOXNOL 9 CONDOM
• Applicant: Medtech Products , Ltd.
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5310
• Device Class: Class 2

Intended Use

The Double Springers Nonoxynol 9 condom,is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Double Springers Nonoxynol 9 lubricated condom; latex sheath with spermicidal lubricant; intended for contraception and prophylactic protection against sexually transmitted diseases; used by individuals during sexual intercourse; provides physical barrier to bodily fluids; spermicide provides additional chemical protection; device is disposable and intended for single use.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory compliance and adherence to established standards for latex condoms and spermicidal lubricants.

Technological Characteristics

Latex condom with nonoxynol-9 spermicidal lubricant; compliant with 21 CFR 884.5310; subject to expiration dating requirements per 21 CFR 801.435; shelf life determined by the earlier of the condom or spermicide expiration.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals seeking barrier protection.

Regulatory Classification

Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

Submission Summary (Full Text)

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Public Health Service

JUN 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. A.V.K. Reddy Chairman & Managing Director Medtech Products Limited S-59, 20th Street Anna Nagar West Chennai 600 040 INDIA

Re: K012969

Double Springers Nonoxynol 9 Lubricated Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: 85 LTZ Dated: May 4, 2002 Received: May 7. 2002

Dear Dr. 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 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 maior 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 (OS) 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.

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Page 2 - Mr. Ah-Kau

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and 8884.5310) 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, 8801.435(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 8807.97). 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

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## INDICATIONS FOR USE STATEMENT VII.

: KO12969 . 510(k) number

: Double Springers Nonoxynol 9 lubricated Device Name

Indications for use : The Double Springers Nonoxynol 9 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)

Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

Aaseuc Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
& ogical Devices
510(k) Number K012969

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