MALE LATEX CONDOM

K132107 · Nulatex Sdn. Bhd. · HIS · Mar 7, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132107
• Device Name: MALE LATEX CONDOM
• Applicant: Nulatex Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 7, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Nulatex Natural Male Latex Condom is used for continception and prophylactic purposes. (To help provent pregnancy and iransmission of sexually transmitted infection)

Device Story

Male latex condom; intended for contraception and prevention of sexually transmitted infections. Device is a physical barrier worn during intercourse. Used in home or private settings; patient self-use. Provides mechanical protection against pregnancy and disease transmission.

Clinical Evidence

No clinical data provided; device is a standard male latex condom.

Technological Characteristics

Natural rubber latex; physical barrier; non-sterile; dimensions and specifications consistent with standard condom regulations.

Indications for Use

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

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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2014

Nulatex Sdn. Bhd. Teo Ai Siang OA Manager Lot 1870, 4th Mile, Jalan Mengkibol Kluang, Johor 86000 Malaysia

Re: K132107

> Trade/Device Name: Male Latex Condom (Natural Vanilla, Natural Banana, Orange Condom. Orange with Orange Flavor, Yellow Condom, Yellow Banana Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 28, 2014 Received: January 31, 2014

Dear Teo Ai Siang,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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,

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Page 2 - Teo Ai Siang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/7 description: The image shows the name "Benjamin Fisher-S" with a logo in the middle. The logo appears to be a stylized version of the letters "FDA". The text is in a simple, sans-serif font and is easy to read. The logo is more intricate and detailed than the text.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Indications for Use

Form'Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013 See PRA: Statement on last page .

#### 510(k) Number (if known) K132107

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#### Device Name

Device Name.
Nale, Later, Condom(Naural Vanilla, Natural Banning, Orange, Continer, Clange, Elavor, Yellow (Singna) (

### Indications for Use (Describe)

Nulatex Natural Male Latex Condom is used for continception and prophylactic purposes.
(To help provent pregnancy and iransmission of sexually transmitted infection)

| Type of Use (Select one or both, as applicable) | <span> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Benjamin R Fisher-S

2014.03.07 18:31:28 -05'00'

| FORM FDA 3881 (9/13) | Page 1 of 2 |
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Allery Comment ..............................................................................................................................................................................

# This section applies only to requirements of the Papenwork Reduction Act of 1986.
-DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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The burden time for this collection of Information is asserge 79 hours per response, including the and review the collection of information. Send comments regarding this burden estimate of any other aspect, of this information collection, theluding suggestions for reducing this burden, to:

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FORM FDA 3881 (9/13)