MULTIPLE BRAND MALE LATEX CONDOM

K070937 · Nulatex Sdn. Bhd. · HIS · Sep 21, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070937
• Device Name: MULTIPLE BRAND MALE LATEX CONDOM
• Applicant: Nulatex Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This [MULTIPLE BRAND] 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).

Device Story

Male natural rubber latex condom; intended for contraception and prophylaxis against sexually transmitted diseases. Device functions as a physical barrier. Used by consumers in over-the-counter settings. Provides protection by preventing exchange of bodily fluids during intercourse.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics typical for latex condoms.

Technological Characteristics

Natural rubber latex material; physical barrier form factor; non-sterile; intended for single use.

Indications for Use

Indicated for use by individuals for contraception and the prevention of pregnancy and 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is depicted with three curved lines representing its wings and a simple representation of its head and body.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## SEP 2 1 2007

Ms. Kim L. Lee Head, OA Department Nulatex Sdn Bhd Lot 1870, 4th Miles, Jalan Mengkibol 86000, Kluang, Johor. MALAYSIA

Re: K070937

Trade Name: [MULTIPLE BRAND] of Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: II Product Codes: LTZ and HIS Dated: August 16, 2007 Received: August 20, 2007

### Dear Ms. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/0/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the abbreviation "PA" in a bold, stylized font. The word "Centennial" is written in a cursive font below the abbreviation. Three stars are arranged in a horizontal line at the bottom of the logo.

relating and Premoting Public Secally

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgdon

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

Enclosure

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# nulatex sdn. bhd. (11871-M)

Lot 1870, 4th Miles, Jalan Mengkibol 86000, Kluang, Johor. Malaysia t [phone] f [phone] e: [e-mail] w: www.nulatex.com

Amended page 22

#### INDICATIONS FOR USE STATEMENT VII.

510(k) Number: K070937

Device Name:

[MULTIPLE BRAND] of Male Natural Rubber Latex Condom

Indications For Use: This {MULTIPLE BRAND] 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).

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K070937 |

| Prescription Use (Per 21 CFR § 801,109) | OR | Over-The-Counter Use <span></span><br><span></span> |
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