MALE NATURAL RUBBER LATEX CONDOM

K053367 · Innolatex Sdn. Bhd · HIS · Feb 21, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K053367
• Device Name: MALE NATURAL RUBBER LATEX CONDOM
• Applicant: Innolatex Sdn. Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 21, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The [No particular brand name] condom is used for prophylactic purposes (to help contraception and for the prevention of pregnancy and the transmission of sexually transmitted diseases).

Device Story

Male natural rubber latex condom; intended for prophylactic use to prevent pregnancy and transmission of sexually transmitted diseases. Device functions as a physical barrier. Used by individuals in a home or personal setting. No specialized operator required. Output is the physical barrier itself; clinical benefit is reduction in risk of unintended pregnancy and disease transmission.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex material; physical barrier form factor; non-sterile (implied by standard condom classification); no electronic components or software.

Indications for Use

Indicated for use by males 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2006

Mr. Goh Miah Kiat General Manager Innolatex Sdn. Bhd. Lot 594, Persiaran Raja Lumu 42000 Port Klang, Selangor Darul Ehsan MALAYSIA

Re: K053367

Trade/Device Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 28, 2005 Received: December 5, 2005

Dear Mr. Kiat:

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 the cholors's to regardy man date of the Medical Device Amendments, or to devices that have been reasy 20, 1710, 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 do not require approvince controls provisions of the Act. The general controls provisions of the Act ac not, subject to the general 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 I tpp. o an 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 Eederal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that I lease of advisou determination that your device complies with other requirements of the Act or any F Drivals made 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 (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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter will anon-you ve arger.
The finding the FDA finding of substantial equivalence of your device to a legally prematice notification: "The 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 If you desire specific acries for your as of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note togalation ecencral information on your responsibilities under the Act from the 807.77). Tod may of Small Manufacturer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

T. Nancy C. Brigdon

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

Enclosure

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## INDICATIONS FOR USE STATEMENT

K053367 510(k) Number:

Male Natural Rubber Latex Condom {No particular brand name] Device Name:

The [No particular brand name] condom is used for Indications For Use: THE [No particular STaprophylactic purposes (to help contraception and for proporty and the transmission of sexually transmitted diseases).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109) OR

Over-The-Counter Use

Nancy Snvaton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Deviçes 510(k) Number .

Counter Use