MALE LATEX CONDOM

K121241 · Nulatex Sdn. Bhd. · HIS · Feb 14, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K121241
• Device Name: MALE LATEX CONDOM
• Applicant: Nulatex Sdn. Bhd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 14, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Nulatex Male Natural Rubber Latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

Male latex condom; intended for contraception and prevention of sexually transmitted infections. Available in various textures (smooth, ribbed, studded, 3-in-1, ultrathin) and colors (natural, pink), with or without strawberry flavoring. Device functions as physical barrier. Used by consumers in non-clinical settings. No electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex material. Physical barrier device. Various textures and colors. No energy source, software, or connectivity.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted infections in individuals using male condoms.

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)

{0}------------------------------------------------

## 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

February 14, 2013

Nulatex SDN. BHD. % Mr. Teo Ai Siang QA Manager Lot 1870, 4th Mile, Jalan Mengkibol KLUANG JOHOR MALAYSIA 86000

Re: K121241

Trade/Device Name: Male Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 18, 2013 Received: February 11, 2013

### Dear Mr. 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. Ilsting 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.

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.

{1}------------------------------------------------

Page 2 - Mr. Teo Ai Siang

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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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

{2}------------------------------------------------

2nd Revised

#### K121241

#### INDICATIONS FOR USE STATEMENT VII.

510 (k) Number :

<121241

Device Name : Male Latex Condom.

> (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.

Indication for use : The Nulatex Male Natural Rubber Latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use OR Over -The-Counter Use X (Per 21 CFR § 801.109)

Benjamin|R.Fisher -S
2013.02.14 17:00:48 -05'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K121241 510(k) Number _

18