NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM

K023128 · Secure Scientific Sdn Bhd · HIS · Jan 22, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K023128
• Device Name: NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
• Applicant: Secure Scientific Sdn Bhd
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jan 22, 2003
• 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 contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Non-spermicidal lubricated male latex condom; intended for contraception and prevention of sexually transmitted diseases. Device is a physical barrier worn by males during intercourse. Used in home or private settings; patient self-use. Provides mechanical protection against pregnancy and disease transmission. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Natural rubber latex material; non-spermicidal lubricant; physical barrier form factor. Complies with 21 CFR 884.5300 and 21 CFR 801.435 regarding expiration dating and shelf-life testing.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 22 2003

Mr. Chong Ngit-Heng Managing Director Secure Scientific SDN. BHD. Lot 122, Kampung Titi Tok Aris, Sungai Seluang, 09600 Lunas, Kedah MALAYSIA

Re: K023128

Trade Name/Device: Non-Spermicidal Lubricated Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: November 30, 2002 Received: December 4, 2002

Dear Mr. Ngit-Heng:

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 major 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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. Ngit-Heng

This letter will allow you to begin marketing your device as described in your 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.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and \$884.5310) 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(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, §801.435(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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §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/cdrh/dsma/dsmamain.html".

Sincerely yours.

David A. Helyum

for

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

KOZ3128 510(k) Number:

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

Indications For Use: The [No particular brand name] 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 (Per 21 CFR § 801.109) OR

1 Over-The-Counter Use

David A. Sejmen

(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number